Meal Glycaemic Index and Exercise After Gastric Bypass

Not Applicable

Completed

• Conditions: Obesity; Roux-en-Y Gastric Bypass
• Interventions: Other: Low GI mealtest; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise

• Registration Number: NCT03478098
• Lead Sponsor: Kirstine Nyvold Bojsen-Moeller

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-06
• Study Start: 2018-03-01
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-27
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 Roux-en-Y Gastric Bypass patients	Low GI mealtest and subsequent exercise	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 control subjects	High GI mealtest and subsequent exercise	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 Roux-en-Y Gastric Bypass patients	Low GI mealtest	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 Roux-en-Y Gastric Bypass patients	High GI mealtest	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 control subjects	High GI mealtest	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 Roux-en-Y Gastric Bypass patients	High GI mealtest and subsequent exercise	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 control subjects	Low GI mealtest and subsequent exercise	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise
10 control subjects	Low GI mealtest	4 study days in randomized order are conducted with interventions: Low GI mealtest, High GI mealtest, Low GI mealtest and subsequent exercise, High GI mealtest and subsequent exercise

Primary Outcome Measures

Name	Time	Method
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention	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
Impact of glycaemic index on nadir plasma glucose within groups for each intervention	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 Outcome Measures

Name	Time	Method
Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC	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
Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration	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
Impact of acute bout of exercise on AUC glucose within groups	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)
Impact of acute bout of exercise on delta-fasting-peak glucose within groups	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
Impact of glycaemic index on AUC glucose within groups	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
Impact of glycaemic index on delta-fasting-peak glucose within groups	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
Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC	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
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	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
Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values	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
Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC	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
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration	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
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC	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
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration	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
Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC	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
Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration	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
Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC	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
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	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

Trial Locations

Locations (1)

Department of Endocrinology, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark