Obesity, Roux-en-Y Gastric Bypass
Conditions
Keywords
Gut hormones, Glucose excursions
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.
Interventions
OTHERLow GI mealtest
Meal with low glycaemic index (GI) is consumed over 20 min
OTHERLow GI mealtest and subsequent exercise
Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
OTHERHigh GI mealtest
Meal with high glycaemic index (GI) is consumed over 20 min
OTHERHigh GI mealtest and subsequent exercise
Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
Sponsors
University of Copenhagen
Kirstine Nyvold Bojsen-Moeller
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Between group differences in delta-nadir-end glucose for each intervention | 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 |
| Between group differences in delta-peak-nadir glucose for each intervention | 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 |
| Between group differences in delta-fasting-to-peak glucose for each intervention | 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 |
| Between group differences in nadir plasma glucose for each intervention | 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 |
| Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention 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 | 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. |
| Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention 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 | 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. |
| Between group differences in ghrelin secretion for each intervention 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 | 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. |
| Between group differences in peptide YY secretion for each intervention 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 | 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. |
| Between group differences in peptide YY secretion for each intervention 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 | 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 |
| Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention 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 | 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 |
| Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention 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 | 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 |
| Between group differences in glucagon secretion for each intervention 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 | 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 |
| Between group differences in insulin secretion for each intervention 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 | 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 |
| Between group differences in insulin secretion for each intervention determined by differences in peak concentration | 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 |
| Between group differences in blood lactate levels for each intervention 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 | 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 |
| Between group differences in blood lactate levels for each intervention 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 | 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 |
| Between group differences in ad libitum food intake for each intervention determined by differences in ingested amount of ad libitum meal in grams | 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 |
| 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 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. |
| Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences peak concentration | 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. |
Countries
Denmark
Outcome results
None listed