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NCT Number: NCT03785379

A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes

Diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, only few studies investigated how exercise could influence patients' RMR and results are still not unanimous. In this study, we aim to investigate the effects on metabolic health of a combined dietary intervention and 12-week exercise training in obese adults with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Although a number of exercise training interventions have been proposed to type 2 diabetes patients, the current clinical practice demonstrates that most patients are still sedentary and with excess body weight. A negative balance between energy intake and energy expenditure is crucial to reduce excess body weight. However, diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, no robust evidence has been collected on this issue, and the few studies that investigated how exercise could influence patients' RMR have not shown unanimous results, especially concerning combined dietary and physical activity interventions.

This open-label randomized trial in obese adults with type 2 diabetes aims to investigate the effects of a 1-year caloric restriction and 12-week exercise training intervention on metabolic health, RMR and VO2max.

In particular, eligible type 2 diabetes patients of our clinic will be invited to participate in a short lifestyle intervention (LSI). LSI will consist of four weekly group-led lessons lasting 60-90 minutes in which specialized professionals will educate patients on specific dietary and physical activity recommendations for improving health and metabolic control.

After this month, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.

Type 2 diabetic and obese adult volunteers will be recruited and screened through medical history, physical examination and biochemical analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • age 30 to 64 years
  • less than 60 min aerobic exercise/week
  • absence of acute diseases
  • no current treatment with insulin or sulfonylureas

Exclusion criteria

  • Body mass index (BMI)<28
  • HbA1c<6%
  • Recent acute diseases, severe infections, trauma or surgery
  • Uncontrolled hypertension or hyperglycemia
  • Evidence of advanced cardiovascular, renal or hepatic diseases
  • Contraindication to exercise
  • Body weight change of more than 3% within the last 6 months
  • Medication changes within the last 3 months

Treatment and study plan

Caloric restriction

Behavioral

A structured dietary training will be implemented to educate participants about recommended dietary habits.Patients will follow a caloric restriction (CR) diet, with an energy intake equal to the measured Resting Metabolic Rate (RMR) and with 45% carbohydrate, 20%protein, 35%fat, and 30 g/day fibers. At each follow-up, nutritionist will adjust CR to the latest measured RMR and assess the compliance to the diet.

Other names: One-year caloric restriction

Exercise Training

Behavioral

Trainers will supervise participants during 12-weeks of structured exercise consisting of 150 min/week workouts, divided in three sessions of progressive mixed (aerobic and resistance) exercise. All aerobic exercise will be performed using treadmill and/or cycle ergo-meter.

Other names: 12-week structured supervised exercise training (SSET)

Primary outcomes

  1. Change from baseline Glycated Hemoglobin (HbA1c) at 6 months

    Time frame: 6 months

    Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.

Secondary outcomes

  1. Change from baseline Resting Metabolic Rate at 3 months

    Time frame: 3 months

    Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures

  2. Change from baseline Resting Metabolic Rate at 6 months

    Time frame: 6 months

    Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures

  3. Change from baseline Resting Metabolic Rate at 12 months

    Time frame: 12 months

    Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures

  4. Change from baseline Body mass index at 3 months

    Time frame: 3 months

    Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared.

  5. Change from baseline Body mass index at 6 months

    Time frame: 6 months

    Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared.

  6. Change from baseline Body mass index at 12 months

    Time frame: 12 months

    Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared.

  7. Change from baseline Fat-free mass at 3 months

    Time frame: 3 months

    Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  8. Change from baseline Fat-free mass at 6 months

    Time frame: 6 months

    Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  9. Change from baseline Fat-free mass at 12 months

    Time frame: 12 months

    Fat mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  10. Change from baseline android to gynoid percent fat ratio at 3 months

    Time frame: 3 months

    Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  11. Change from baseline android to gynoid percent fat ratio at 6 months

    Time frame: 6 months

    Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  12. Change from baseline android to gynoid percent fat ratio at 12 months

    Time frame: 12 months

    Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).

  13. Change from baseline fasting plasma glucose at 3 months

    Time frame: 3 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.

  14. Change from baseline fasting plasma glucose at 6 months

    Time frame: 6 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.

  15. Change from baseline fasting plasma glucose at 12 months

    Time frame: 12 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.

  16. Change from baseline HDL cholesterol at 3 months

    Time frame: 3 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.

  17. Change from baseline HDL cholesterol at 6 months

    Time frame: 6 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.

  18. Change from baseline HDL cholesterol at 12 months

    Time frame: 12 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.

  19. Change from baseline total cholesterol at 3 months

    Time frame: 3 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.

  20. Change from baseline total cholesterol at 6 months

    Time frame: 6 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.

  21. Change from baseline total cholesterol at 12 months

    Time frame: 12 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.

  22. Change from baseline triglycerides levels at 3 months

    Time frame: 3 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.

  23. Change from baseline triglycerides levels at 6 months

    Time frame: 6 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.

  24. Change from baseline triglycerides levels at 12 months

    Time frame: 12 months

    Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.

  25. Change from baseline serum creatinine at 3 months

    Time frame: 3 months

    Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.

  26. Change from baseline serum creatinine at 6 months

    Time frame: 6 months

    Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.

  27. Change from baseline serum creatinine at 12 months

    Time frame: 12 months

    Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.

  28. Change from baseline urinary albumin-to-creatinine ratio at 3 months

    Time frame: 3 months

    Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.

  29. Change from baseline urinary albumin-to-creatinine ratio at 6 months

    Time frame: 6 months

    Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.

  30. Change from baseline urinary albumin-to-creatinine ratio at 12 months

    Time frame: 12 months

    Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.

  31. Change from baseline maximal aerobic power at 3 months

    Time frame: 3 months

    VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.

  32. Change from baseline maximal aerobic power at 6 months

    Time frame: 6 months

    VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.

  33. Change from baseline maximal aerobic power at 12 months

    Time frame: 12 months

    VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.

  34. Change from baseline Glycated Hemoglobin (HbA1c) at 3 months

    Time frame: 3 months

    Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.

  35. Change from baseline Glycated Hemoglobin (HbA1c) at 12 months

    Time frame: 12 months

    Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

A Randomized Trial Evaluating the Effects of One-Year Caloric Restriction and 12-Week Exercise Training Intervention in Obese Adults With Type 2 Diabetes: Emphasis on Metabolic Control and Resting Metabolic Rate

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2018
Registry last updated
Dec 24, 2018

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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