Meal Glycaemic Index and Exercise After Gastric Bypass

NCT03478098 | Completed DMC

• 1 other identifier: ExRYGB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Roux-en-Y Gastric Bypass; Obesity

Keywords

Gut hormones; Glucose excursions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (19)

• 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

• 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

• 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

Study Arms (2)

10 Roux-en-Y Gastric Bypass patients

EXPERIMENTAL

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; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise

10 control subjects

EXPERIMENTAL

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; Other: Low GI mealtest and subsequent exercise; Other: High GI mealtest; Other: High GI mealtest and subsequent exercise

Interventions

Low GI mealtest OTHER

Meal with low glycaemic index (GI) is consumed over 20 min

10 Roux-en-Y Gastric Bypass patients; 10 control subjects

Low GI mealtest and subsequent exercise OTHER

Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min

10 Roux-en-Y Gastric Bypass patients; 10 control subjects

High GI mealtest OTHER

Meal with high glycaemic index (GI) is consumed over 20 min

10 Roux-en-Y Gastric Bypass patients; 10 control subjects

High GI mealtest and subsequent exercise OTHER

Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min

10 Roux-en-Y Gastric Bypass patients; 10 control subjects

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.

Sponsors & Collaborators

• Kirstine Nyvold Bojsen-Moeller: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirstine N Bojsen-Moller, MD, PhD

  Department of Endocrinology, Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kirstine Nyvold Bojsen-Moeller

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 27, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

DK (1)