Meal Glycaemic Index and Exercise After Gastric Bypass

Study Overview
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Brief Summary
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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.

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

Conditions
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Roux-en-Y Gastric Bypass, Obesity

Intervention / Treatment
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* Other: Low GI mealtest
* Other: Low GI mealtest and subsequent exercise
* Other: High GI mealtest
* Other: High GI mealtest and subsequent exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut hormones, Glucose excursions