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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Bariatric Surgery Candidate; PreDiabetes; Obesity, Morbid

Treatments: Other: Energy-matched standard diet; Other: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03880162

CaPrO

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Study intervention

Experimental group

Description:

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

Treatment:

Other: Low carbohydrate diet

Control intervention

Active Comparator group

Description:

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

Treatment:

Other: Energy-matched standard diet