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Meal Glycaemic Index and Exercise After Gastric Bypass

K

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

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)

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

Trial contacts and locations

1

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Central trial contact

Sten Madbad, DMSci; Kirstine N Bojsen-Moller

Data sourced from clinicaltrials.gov

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