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Completed

NCT Number: NCT04922970

Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.

Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.

In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.

Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.

The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.

If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.

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Key information

Conditions

Stem Cell Transplant Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Late Effect Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Copenhagen - Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
  • ≥ 18 years old

Exclusion criteria

  • Illness or physical handicap making it impossible to participate in the training intervention
  • Pregnancy
  • Not Danish or English speaking
  • Anemia
  • Already performing regular structured physical training
  • Strict vegan or vegetarian diet
  • Illness or ongoing treatment that hinders study examinations

Treatment and study plan

Strength training

Other

The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.

Primary outcomes

  1. Changes in cross sectional area of m. quadricpes femoris.

    Time frame: 1 week pre intervention

    Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.

  2. Changes in cross sectional area of m. quadricpes femoris.

    Time frame: 1 week post intervention

    Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.

Secondary outcomes

  1. Changes in components of the Metabolic Syndrome: Waist circumference

    Time frame: 1 week pre intervention

    Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  2. Changes in components of the Metabolic Syndrome: Waist circumference

    Time frame: 1 week post intervention

    Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  3. Changes in components of the Metabolic Syndrome: Triglycerides

    Time frame: 1 week pre intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  4. Changes in components of the Metabolic Syndrome: Triglycerides

    Time frame: 1 week post intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  5. Changes in components of the Metabolic Syndrome: HDL-cholesterol

    Time frame: 1 week pre intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  6. Changes in components of the Metabolic Syndrome: HDL-cholesterol

    Time frame: 1 week post intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  7. Changes in components of the Metabolic Syndrome: Fasting glucose

    Time frame: 1 week pre intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  8. Changes in components of the Metabolic Syndrome: Fasting glucose

    Time frame: 1 week post intervention

    Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  9. Changes in components of the Metabolic Syndrome: Blood pressure

    Time frame: 1 week pre intervention

    Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.

    Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  10. Changes in components of the Metabolic Syndrome: Blood pressure

    Time frame: 1 week post intervention

    Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.

    Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

  11. Hip circumference

    Time frame: 1 week pre intervention

    Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.

  12. Hip circumference

    Time frame: 1 week post intervention

    Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.

  13. Urine sample - microalbuminurea

    Time frame: 1 week pre intervention

    A urine sample for analyses of microalbuminurea in mg/L.

  14. Urine sample - microalbuminurea

    Time frame: 1 week post intervention

    A urine sample for analyses of microalbuminurea in mg/L.

  15. Muscle strength of quadriceps femoris

    Time frame: 1 week pre intervention

    Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer

  16. Muscle strength of quadriceps femoris

    Time frame: 1 week post intervention

    Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer

  17. Handgrip strength

    Time frame: 1 week pre intervention

    Handgrip strength measured with handheld Dynamometer

  18. Handgrip strength

    Time frame: 1 week post intervention

    Handgrip strength measured with handheld Dynamometer

  19. Muscle performance: Timed-up-and-go

    Time frame: 1 week pre intervention

    Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.

  20. Muscle performance: Timed-up-and-go

    Time frame: 1 week post intervention

    Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.

  21. Muscle performance: Sit-to-stand 30 sec.

    Time frame: 1 week pre intervention

    Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

  22. Muscle performance: Sit-to-stand 30 sec.

    Time frame: 1 week post intervention

    Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

  23. Muscle performance: Sit-to-stand 60 sec.

    Time frame: 1 week pre intervention

    Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

  24. Muscle performance: Sit-to-stand 60 sec.

    Time frame: 1 week post intervention

    Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

  25. Cardiorespiratory fitness: 6 minute walk test

    Time frame: 1 week pre intervention

    6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.

  26. Cardiorespiratory fitness: 6 minute walk test

    Time frame: 1 week post intervention

    6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.

Other outcomes

  1. Histology of thigh muscle

    Time frame: 1 week pre intervention

    Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.

  2. Histology of thigh muscle

    Time frame: 1 week post intervention

    Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.

  3. Body composition: Intraabdominal visceral fat

    Time frame: 1 week pre intervention

    Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.

  4. Body composition: Intraabdominal visceral fat

    Time frame: 1 week post intervention

    Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.

  5. Body composition: Abdominal subcutaneous fat

    Time frame: 1 week pre intervention

    Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.

  6. Body composition: Abdominal subcutaneous fat

    Time frame: 1 week post intervention

    Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.

  7. Body composition: Hepatic fat

    Time frame: 1 week pre intervention

    Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.

  8. Body composition: Hepatic fat

    Time frame: 1 week post intervention

    Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.

  9. Body composition: Fat mass

    Time frame: 1 week pre intervention

    Body fat mass (%) will be analyzed on a whole-body DEXA scan

  10. Body composition: Fat mass

    Time frame: 1 week post intervention

    Body fat mass (%) will be analyzed on a whole-body DEXA scan

  11. Body composition: Fat free mass

    Time frame: 1 week pre intervention

    Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan

  12. Body composition: Fat free mass

    Time frame: 1 week post intervention

    Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan

  13. Body composition: Android-gynoid ratio

    Time frame: 1 week pre intervention

    Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan

  14. Body composition: Android-gynoid ratio

    Time frame: 1 week post-intervention

    Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan

  15. Body composition: Bone mineral density

    Time frame: 1 week pre intervention

    Bone mineral density, will be analyzed on a whole-body DEXA scan. Z- and T-scores will be calculated.

  16. Body composition: Bone mineral density

    Time frame: 1 week post intervention

    Bone mineral density, will be analyzed on a whole-body DEXA scan. Z- and T-scores will be calculated.

  17. Body mass index (BMI)

    Time frame: 1 week pre intervention

    BMI will be calculated based on measurements of height and weight. To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm. Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes. BMI is calculated as wieght in kg diveded by height in meters squared.

  18. Body mass index (BMI)

    Time frame: 1 week post intervention

    BMI will be calculated based on measurements of height and weight. To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm. Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes. BMI is calculated as wieght in kg diveded by height in meters squared.

  19. Total-cholesterol

    Time frame: 1 week pre intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  20. Total-cholesterol

    Time frame: 1 week post intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  21. LDL-cholesterol

    Time frame: 1 week pre intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  22. LDL-cholesterol

    Time frame: 1 week post intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  23. Adipokines: Adiponectin

    Time frame: 1 week pre intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  24. Adipokines: Adiponectin

    Time frame: 1 week post intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  25. Adipokines: Leptin

    Time frame: 1 week pre intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  26. Adipokines: Leptin

    Time frame: 1 week post intervention

    Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  27. Growth factors

    Time frame: 1 week pre intervention

    Growth factors, i.e. IGF-1 and IGFBP-3, will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  28. Growth factors

    Time frame: 1 week post intervention

    Growth factors, i.e. IGF-1 and IGFBP-3, will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  29. Thyroid hormones

    Time frame: 1 week pre intervention

    Thyroid hormones, free triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  30. Thyroid hormones

    Time frame: 1 week post intervention

    Thyroid hormones, triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  31. Sex hormones

    Time frame: 1 week pre intervention

    Analyses of sex hormones, including testosterone and estrogen levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  32. Sex hormones

    Time frame: 1 week post intervention

    Analyses of sex hormones, including testosterone and estrogen levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  33. Markers of inflammation

    Time frame: 1 week pre intervention

    Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  34. Markers of inflammation

    Time frame: 1 week post intervention

    Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.

  35. Oral glucose tolerance test: Glucose

    Time frame: 1 week pre intervention

    Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  36. Oral glucose tolerance test: Glucose

    Time frame: 1 week post intervention

    Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  37. Oral glucose tolerance test: Insulin

    Time frame: 1 week pre intervention

    Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  38. Oral glucose tolerance test: Insulin

    Time frame: 1 week post intervention

    Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  39. Oral glucose tolerance test: C-peptide

    Time frame: 1 week pre intervention

    Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  40. Oral glucose tolerance test: C-peptide

    Time frame: 1 week post intervention

    Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  41. Oral glucose tolerance test: Gut hormones

    Time frame: 1 week pre intervention

    Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  42. Oral glucose tolerance test: Gut hormones

    Time frame: 1 week post intervention

    Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  43. Oral glucose tolerance test: Bone remodeling markers

    Time frame: 1 week pre intervention

    Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  44. Oral glucose tolerance test: Bone remodeling markers

    Time frame: 1 week post intervention

    Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  45. Health related quality of life - SF36

    Time frame: 1 week pre intervention

    Measure of health related quality of life, by the validated questionnaire SF-36. Outcome will be total score based o the questionnaire.

  46. Health related quality of life - SF36

    Time frame: 1 week post intervention

    Measure of health related quality of life, by the validated questionnaire SF-36. Outcome will be total score based o the questionnaire.

  47. Accelerometry using actigraph

    Time frame: 1 week pre intervention

    measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day

  48. Accelerometry using actigraph

    Time frame: 1 week post intervention

    measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day and minutes in moderate to vigorous activity

  49. Oral glucose tolerance test: Matsuda Index

    Time frame: 1 week pre intervention

    Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  50. Oral glucose tolerance test: Matsuda Index

    Time frame: 1 week post intervention

    Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  51. Oral glucose tolerance test: Insulinogenic Index

    Time frame: 1 week pre intervention

    Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

  52. Oral glucose tolerance test: Insulinogenic Index

    Time frame: 1 week post intervention

    Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • Danish Child Cancer Foundation
  • The Danish Cancer Research Foundation
  • University of Copenhagen

Registry information

Acronym: STEPS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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