Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from baseline in intrahepatic triglyceride content
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change from baseline in intrahepatic triglyceride content
Time Frame: 2 weeks
The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy
Secondary Outcomes
- Change from baseline in liver size(2 weeks)
- Change from baseline in whole body fat mass(2 weeks)
- Change from baseline in body weight(2 weeks)
- Change from baseline in insulin secretion(2 weeks)
- Change from baseline in visceral adipose tissue(2 weeks)
- Change from baseline in insulin sensitivity(2 weeks)