CompletedNot Applicable

Meal Glycaemic Index and Exercise After Gastric Bypass

Denmark20 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT03478098

SponsorKirstine Nyvold Bojsen-Moeller

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-01

View on ClinicalTrials.gov More Roux-en-Y Gastric Bypass trials

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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