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Completed

NCT Number: NCT03478098

Meal Glycaemic Index and Exercise After Gastric Bypass

The study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects.

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Key information

Conditions

Roux-en-y Gastric Bypass Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

RYGB patients:

Inclusion criteria

  • Undergone Roux-en-Y gastric bypass (RYGB) without complications at least 12 months prior to inclusion.
  • Achieved > 50% Excess BMI Loss
  • Weight stability (no fluctuations over ± 5 kg the last 3 months)
  • HBA1c < 48 mmol/mol before and after surgery without the use of anti-diabetic medication
  • The participant must be able to ingest the meals

Exclusion criteria

  • Low hemoglobin levels (< 6.5 mM)
  • Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
  • Dysregulated thyroid gland affection
  • The use of medication which affects heart frequency (i.e. Beta-blockers)
  • Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).

Control group:

Inclusion criteria

  • Matched with the RYGB patients on gender, age (± 5 years), menopausal state (pre- versus post-menopausal) and BMI (± 3 points).
  • Weight stable ( ± 5 kg during 3 months)
  • HBA1c < 48 mmol/mol

Exclusion criteria

  • Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.

Treatment and study plan

Low GI mealtest

Other

Meal with low glycaemic index (GI) is consumed over 20 min

Low GI mealtest and subsequent exercise

Other

Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min

High GI mealtest

Other

Meal with high glycaemic index (GI) is consumed over 20 min

High GI mealtest and subsequent exercise

Other

Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min

Primary outcomes

  1. Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention

    Time frame: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal

    Comparison of nadir plasma glucose in response to an acute bout of exercise internally in groups a) RYGB and b) control group

  2. Impact of glycaemic index on nadir plasma glucose within groups for each intervention

    Time frame: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal

    Comparison of nadir plasma glucose in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group

Secondary outcomes

  1. Impact of acute bout of exercise on AUC glucose within groups

    Time frame: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Comparison of plasma glucose excursions in response to an acute bout of exercise internally in groups a) RYGB and b) control group determined by differences in area under curve (AUC)

  2. Impact of acute bout of exercise on delta-fasting-peak glucose within groups

    Time frame: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Comparison of plasma glucose excursions in response to an acute bout of exercise internally in groups a) RYGB and b) control group determined by delta-fasting-to-peak concentrations of glucose

  3. Impact of glycaemic index on AUC glucose within groups

    Time frame: AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Comparison of plasma glucose excursions in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group determined by differences in area-under-the-curve of glucose

  4. Impact of glycaemic index on delta-fasting-peak glucose within groups

    Time frame: Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Comparison of plasma glucose excursions in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group determined by differences in delta-fasting-peak glucose

  5. Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC

    Time frame: AUC for time concentration curve of GLP-1 at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    AUC GLP-1 will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  6. Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in peak concentration

    Time frame: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Peak GLP-1 will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  7. Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values

    Time frame: Decremental AUC for the time concentration curve of ghrelin at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    decremental AUC of ghrelin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  8. Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC

    Time frame: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    AUC PYY will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  9. Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration

    Time frame: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Peak PYY will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  10. Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC

    Time frame: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    AUC GIP will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  11. Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration

    Time frame: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Peak GIP will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  12. Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC

    Time frame: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    AUC glucagon will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  13. Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC

    Time frame: AUC of the time-concentration curve of lactate at 0, 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal

    AUC lactate will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  14. Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration

    Time frame: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal

    Peak lactate will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  15. Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC

    Time frame: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    AUC insulin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  16. Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration

    Time frame: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Peak insulin will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise within the RYGB and control group

  17. Impact of postprandial exercise and meal glycaemic index on ad libitum food intake within the groups determined by differences in ingested amount of ad libitum meal in grams

    Time frame: at 240 min following ingestion of test meal

    Grams of ad libitum food intake. Food will be served at 240 minutes after fixed breakfast meal

Other outcomes

  1. Between group differences in delta-fasting-to-peak glucose for each intervention

    Time frame: difference between fasting glucose and highest glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Impact of exercise on glucose excursions between RYGB vs Control, impact of meal glycaemic index on glucose excursions between RYGB vs Control determined by differences in delta-fasting-to-peak glucose

  2. Between group differences in delta-peak-nadir glucose for each intervention

    Time frame: Difference from highest plasma glucose to subsequent lowest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Impact of exercise on glucose excursions between RYGB vs Control, impact of meal glycemic index on glucose excursions between RYGB vs Control determined by differences in delta-peak-nadir glucose

  3. Between group differences in nadir plasma glucose for each intervention

    Time frame: Lowest glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Impact of exercise on glucose excursions between RYGB vs Control, impact of meal glycemic index on glucose excursions between RYGB vs Control determined by differences in nadir glucose

  4. Between group differences in delta-nadir-end glucose for each intervention

    Time frame: Difference from lowest glucose to end study glucose 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal

    Impact of exercise on glucose excursions between RYGB vs Control, impact of meal glycemic index on glucose excursions between RYGB vs Control determined by differences in delta-nadir-end glucose

  5. Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in AUC

    Time frame: AUC for time concentration curve of GLP-1 at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on GLP-1 secretion between RYGB vs Control, impact of meal glycemic index on GLP-1 secretion between RYGB vs Control determined by differences in AUC.

  6. Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in peak concentration

    Time frame: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on GLP-1 secretion between RYGB vs Control, impact of meal glycemic index on GLP-1 secretion between RYGB vs Control determined by differences in peak concentration.

  7. Between group differences in ghrelin secretion for each intervention determined by differences in suppression from basal values

    Time frame: Decremental AUC for the time concentration curve of ghrelin at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on ghrelin secretion between RYGB vs Control, impact of meal glycemic index on ghrelin secretion between RYGB vs Control determined by differences in decremental AUC.

  8. Between group differences in peptide YY secretion for each intervention determined by differences in AUC

    Time frame: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on peptide YY secretion between RYGB vs Control, impact of meal glycemic index on peptide YY secretion between RYGB vs Control determined by differences in AUC.

  9. Between group differences in peptide YY secretion for each intervention determined by differences in peak concentration

    Time frame: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on peptide YY secretion between RYGB vs Control, impact of meal glycemic index on peptide YY secretion between RYGB vs Control determined by differences in peak concentration

  10. Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in AUC

    Time frame: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on GIP secretion between RYGB vs Control, impact of meal glycemic index on GIP secretion between RYGB vs Control determined by differences in AUC

  11. Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in peak concentration

    Time frame: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on GIP secretion between RYGB vs Control, impact of meal glycemic index on GIP secretion between RYGB vs Control determined by differences in peak concentration

  12. Between group differences in glucagon secretion for each intervention determined by differences in AUC

    Time frame: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on glucagon secretion between RYGB vs Control, impact of meal glycemic index on glucagon secretion between RYGB vs Control determined by differences in AUC

  13. Between group differences in insulin secretion for each intervention determined by differences in AUC

    Time frame: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on insulin secretion between RYGB vs Control, impact of meal glycemic index on insulin secretion between RYGB vs Control determined by differences in AUC

  14. Between group differences in insulin secretion for each intervention determined by differences in peak concentration

    Time frame: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on insulin secretion between RYGB vs Control, impact of meal glycemic index on insulin secretion between RYGB vs Control determined by differences in peak concentration

  15. Between group differences in blood lactate levels for each intervention determined by differences in AUC

    Time frame: AUC of the time-concentration curve of lactate at 0, 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on blood lactate levels between RYGB vs Control, impact of meal glycemic index on blood lactate levels between RYGB vs Control determined by differences in AUC

  16. Between group differences in blood lactate levels for each intervention determined by differences in peak concentration

    Time frame: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal

    Impact of exercise on blood lactate levels between RYGB vs Control, impact of meal glycemic index on blood lactate levels between RYGB vs Control determined by differences in peak concentration

  17. Between group differences in ad libitum food intake for each intervention determined by differences in ingested amount of ad libitum meal in grams

    Time frame: at 240 min following ingestion of test meal

    Impact of exercise on ad libitum food intake between RYGB vs Control, impact of meal glycemic index on ad libitum food intake between RYGB vs Control determined by differences in ingested amount of ad libitum meal in grams. Food will be served at 240 minutes after fixed breakfast meal

  18. Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences in time-to-peak

    Time frame: Time to highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Time-to-peak paracetamol will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise between the RYGB vs control groups.

  19. Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences peak concentration

    Time frame: Highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal

    Peak paracetamol will be compared for meals with high vs low glycaemic index and with and without acute bout of exercise between the RYGB vs control groups.

Sponsors and collaborators

Lead sponsor

Kirstine Nyvold Bojsen-Moeller

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Importance of Glycaemic Index and Exercise on Postprandial Glucose Excursions and Gut Hormone Secretion Following Roux-en-Y Gastric Bypass

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2018
Registry last updated
Jun 15, 2023

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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