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

Insel Gruppe AG, University Hospital Bern20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

PreDiabetes Obesity, Morbid Bariatric Surgery Candidate

Interventions

Low carbohydrate dietOTHER

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

Energy-matched standard dietOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Bern, Switzerland

Outcomes

Primary Outcomes

Change from baseline in intrahepatic triglyceride content

The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy

Time frame: 2 weeks

Secondary Outcomes

Change from baseline in body weight

The body weight will be measured using a pre-defined person scale

Time frame: 2 weeks

Change from baseline in liver size

The liver size will be evaluated by magnetic resonance imaging

Time frame: 2 weeks

Change from baseline in visceral adipose tissue

The adipose tissue content will be evaluated by magnetic resonance imaging

Time frame: 2 weeks

Change from baseline in whole body fat mass

Fat mass will be evaluated by bioimpedance

Time frame: 2 weeks

Change from baseline in insulin secretion

The insulin secretion will be evaluated during an oral glucose tolerance test using the oral minimal model

Time frame: 2 weeks

Change from baseline in insulin sensitivity

The insulin sensitivity will be evaluated during an oral glucose tolerance test using the oral minimal model

Time frame: 2 weeks

Data from ClinicalTrials.gov

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