Meal Glycaemic Index and Exercise After Gastric Bypass

Kirstine Nyvold Bojsen-Moeller

Status: Completed

Conditions: Obesity; Roux-en-Y Gastric Bypass

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03478098

ExRYGB

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

10 Roux-en-Y Gastric Bypass patients

Experimental group

Description:

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

Treatment:

Other: High GI mealtest

Other: Low GI mealtest and subsequent exercise

Other: High GI mealtest and subsequent exercise

Other: Low GI mealtest

10 control subjects

Experimental group

Description:

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

Treatment:

Other: High GI mealtest

Other: Low GI mealtest and subsequent exercise

Other: High GI mealtest and subsequent exercise

Other: Low GI mealtest