Clinical trial NCT03478098: Meal Glycaemic Index and Exercise After Gastric Bypass
Official title: The Importance of Glycaemic Index and Exercise on Postprandial Glucose Excursions and Gut Hormone Secretion Following Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Roux-en-Y Gastric Bypass
Obesity
Keywords: Gut hormones
Glucose excursions
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Exclusion Criteria:

* Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.

Primary outcomes:
measure: Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention
timeFrame: 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
measure: Impact of glycaemic index on nadir plasma glucose within groups for each intervention
timeFrame: 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 outcomes:
measure: Impact of acute bout of exercise on AUC glucose within groups
timeFrame: 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
measure: Impact of acute bout of exercise on delta-fasting-peak glucose within groups
timeFrame: 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
measure: Impact of glycaemic index on AUC glucose within groups
timeFrame: 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
measure: Impact of glycaemic index on delta-fasting-peak glucose within groups
timeFrame: 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
measure: Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC
timeFrame: 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
measure: 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
timeFrame: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values
timeFrame: 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
measure: Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC
timeFrame: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration
timeFrame: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC
timeFrame: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration
timeFrame: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC
timeFrame: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC
timeFrame: 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
measure: Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration
timeFrame: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC
timeFrame: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration
timeFrame: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: 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
timeFrame: at 240 min following ingestion of test meal
Other outcomes:
measure: Between group differences in delta-fasting-to-peak glucose for each intervention
timeFrame: 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
measure: Between group differences in delta-peak-nadir glucose for each intervention
timeFrame: 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
measure: Between group differences in nadir plasma glucose for each intervention
timeFrame: 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
measure: Between group differences in delta-nadir-end glucose for each intervention
timeFrame: 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
measure: Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in AUC
timeFrame: 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
measure: Between group differences in Glucagon like peptide-1 (GLP-1) secretion for each intervention determined by differences in peak concentration
timeFrame: Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in ghrelin secretion for each intervention determined by differences in suppression from basal values
timeFrame: 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
measure: Between group differences in peptide YY secretion for each intervention determined by differences in AUC
timeFrame: AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in peptide YY secretion for each intervention determined by differences in peak concentration
timeFrame: Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in AUC
timeFrame: AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in Glucose-dependent insulinotropic peptide (GIP) secretion for each intervention determined by differences in peak concentration
timeFrame: Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in glucagon secretion for each intervention determined by differences in AUC
timeFrame: AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in insulin secretion for each intervention determined by differences in AUC
timeFrame: AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in insulin secretion for each intervention determined by differences in peak concentration
timeFrame: Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in blood lactate levels for each intervention determined by differences in AUC
timeFrame: 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
measure: Between group differences in blood lactate levels for each intervention determined by differences in peak concentration
timeFrame: Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in ad libitum food intake for each intervention determined by differences in ingested amount of ad libitum meal in grams
timeFrame: at 240 min following ingestion of test meal
measure: Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences in time-to-peak
timeFrame: Time to highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal
measure: Between group differences in blood levels of paracetamol ingested with fixed breakfast meal for each intervention determined by differences peak concentration
timeFrame: Highest paracetamol at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240 min after ingestion of meal
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology, Hvidovre Hospital
Study officials:
affiliation: Department of Endocrinology, Hvidovre Hospital
name: Kirstine N Bojsen-Moller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: