Meal Glycaemic Index and Exercise After Gastric Bypass

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478098
• Other study ID #: ExRYGB
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Roux-en-Y Gastric Bypass

Intervention

Other:
• Low GI mealtest
Meal with low glycaemic index (GI) is consumed over 20 min
• 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
• High GI mealtest
Meal with high glycaemic index (GI) is consumed over 20 min
• 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

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hvidovre Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Kirstine Nyvold Bojsen-Moeller	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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