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Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes

NCT ID: NCT03880162

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2024-05-03

Brief Summary

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To investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.

Detailed Description

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The metabolic benefits of calorie restriction in obese people with or without impaired glycaemia are well-established. The impact of diet composition, however, remains poorly understood. Hepatic lipid content strongly correlates with hepatic insulin resistance, which is a key feature of the pre-diabetic state. The investigators hypothesize that a low carbohydrate diet compared to an energy-matched standard diet in morbidly obese patients with prediabetes scheduled for bariatric surgery results in greater reduction in liver fat.

Conditions

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PreDiabetes Obesity, Morbid Bariatric Surgery Candidate

Keywords

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Prediabetes Bariatric Surgery Low-carb diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-centre, randomized parallel study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study intervention

Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks.

Group Type EXPERIMENTAL

Low carbohydrate diet

Intervention Type OTHER

A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)

Control intervention

Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks.

Group Type ACTIVE_COMPARATOR

Energy-matched standard diet

Intervention Type OTHER

Energy-matched (30% deficit) standard diet (50% of carbohydrates)

Interventions

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Low carbohydrate diet

A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)

Intervention Type OTHER

Energy-matched standard diet

Energy-matched (30% deficit) standard diet (50% of carbohydrates)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male subjects aged 18 years or older
* BMI \>35 kg/m2 awaiting bariatric surgery
* Pre-diabetes according to American Diabetes Association criteria (HbA1c 5.7%-6.4%)
* Capacity to give informed consent and adhere to study procedures

Exclusion Criteria

* Excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women)
* Moderate to severe kidney disease
* Nephrolithiasis
* Pregnancy/breastfeeding
* Current participation in another clinical trial
* Claustrophobia
* MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lia Bally, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital, University of Bern

Locations

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Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CaPrO

Identifier Type: -

Identifier Source: org_study_id