Meal Glycaemic Index and Exercise After Gastric Bypass

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

Study Overview

• Status: Completed
• Conditions: Obesity; Roux-en-Y Gastric Bypass
• Intervention / Treatment: Other: Low GI mealtest; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirstine N Bojsen-Moller; Phone Number: +4538626371; Email: kirstine.bojsen-moeller@regionh.dk
• Study Contact Backup: Name: Sten Madbad, DMSci; Phone Number: +4538626371; Email: sten.madsbad@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, DK-2650
    • Department of Endocrinology, Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 Roux-en-Y Gastric Bypass patients; 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	Other: Low GI mealtest; Meal with low glycaemic index (GI) is consumed over 20 min; Other: Low GI mealtest and subsequent exercise; Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min; Other: High GI mealtest; Meal with high glycaemic index (GI) is consumed over 20 min; Other: High GI mealtest and subsequent exercise; Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
Experimental: 10 control subjects; 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	Other: Low GI mealtest; Meal with low glycaemic index (GI) is consumed over 20 min; Other: Low GI mealtest and subsequent exercise; Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min; Other: High GI mealtest; Meal with high glycaemic index (GI) is consumed over 20 min; Other: High GI mealtest and subsequent exercise; Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention	Comparison of nadir plasma glucose in response to an acute bout of exercise internally in groups a) RYGB and b) control group	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
Impact of glycaemic index on nadir plasma glucose within groups for each intervention	Comparison of nadir plasma glucose in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of acute bout of exercise on AUC glucose within groups	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)	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
Impact of acute bout of exercise on delta-fasting-peak glucose within groups	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	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
Impact of glycaemic index on AUC glucose within groups	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	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
Impact of glycaemic index on delta-fasting-peak glucose within groups	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	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
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 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	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 postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in peak concentration	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	Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values	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	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 postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC	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	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 postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration	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	Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC	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	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 postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration	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	Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC	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	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 postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC	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	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 postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration	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	Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC	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	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 postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration	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	Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
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	Grams of ad libitum food intake. Food will be served at 240 minutes after fixed breakfast meal	at 240 min following ingestion of test meal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group differences in delta-fasting-to-peak glucose for each intervention	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	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
Between group differences in delta-peak-nadir glucose for each intervention	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	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
Between group differences in nadir plasma glucose for each intervention	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	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
Between group differences in delta-nadir-end glucose for each intervention	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	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
Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in AUC	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.	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
Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in peak concentration	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.	Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in ghrelin secretion for each intervention determined by differences in suppression from basal values	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.	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
Between group differences in peptide YY secretion for each intervention determined by differences in AUC	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.	AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in peptide YY secretion for each intervention determined by differences in peak concentration	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	Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in AUC	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	AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in peak concentration	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	Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in glucagon secretion for each intervention determined by differences in AUC	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	AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in insulin secretion for each intervention determined by differences in AUC	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	AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in insulin secretion for each intervention determined by differences in peak concentration	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	Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in blood lactate levels for each intervention determined by differences in AUC	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	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
Between group differences in blood lactate levels for each intervention determined by differences in peak concentration	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	Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
Between group differences in ad libitum food intake for each intervention determined by differences in ingested amount of ad libitum meal in grams	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	at 240 min following ingestion of test meal
Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences in time-to-peak	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.	Time to highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences peak concentration	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.	Highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal

Collaborators and Investigators

• Sponsor: Kirstine Nyvold Bojsen-Moeller
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Kirstine N Bojsen-Moller, MD, PhD, Department of Endocrinology, Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gut hormones; Glucose excursions
• Other Study ID Numbers: ExRYGB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No