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

PreDiabetes Clinical Trial

— CaPrO  

Official title:

Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03880162
• Other study ID #: CaPrO
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Glucose Intolerance
• Obesity, Morbid
• PreDiabetes
• Prediabetic State

Intervention

Other:
• Low carbohydrate diet
A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)
• Energy-matched standard diet
Energy-matched (30% deficit) standard diet (50% of carbohydrates)

Locations

Country	Name	City	State
Switzerland	Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in plasma metabolome	Fasting serum sampling	2 weeks
Other	Change from baseline in plasma transcriptome	Fasting serum sampling	2 weeks
Other	Change from baseline in Fibroblast Growth Factor 21	Plasma level	2 weeks
Other	Change from baseline in adipose tissue inflammation	Adipose tissue histology	2 weeks
Other	Change from baseline in gut microbiota composition	Distribution of the predominant bacterial phylotypes will be assessed after 16S rRNA amplicon sequencing and subsequent taxonomic classification	2 weeks
Other	Change from baseline levels of secondary bile acids	Faecal sampling	2 weeks
Other	Change in frequency of immune cells (T-, B-, NK-cells, monocytes, neutrophils)	Frequency of immune cells will be analysed using flowcytometry	2 weeks
Other	Change in immunometabolism of T-cells	Immunometabolism will be assessed by quantifying rates of oxygen consumption and glycolysis using metabolic flux analysis	2 weeks
Other	Occurrence of surgical complication	Occurrence of the following: anastomotic leak, infection, bleeding, deep venous thrombosis (based on medical records)	Day of surgery until 2 weeks post-surgery
Other	Length of hospital stay	Based on medical records	Day of surgery until 2 weeks post-surgery
Primary	Change from baseline in intrahepatic triglyceride content	The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy	2 weeks
Secondary	Change from baseline in body weight	The body weight will be measured using a pre-defined person scale	2 weeks
Secondary	Change from baseline in liver size	The liver size will be evaluated by magnetic resonance imaging	2 weeks
Secondary	Change from baseline in visceral adipose tissue	The adipose tissue content will be evaluated by magnetic resonance imaging	2 weeks
Secondary	Change from baseline in whole body fat mass	Fat mass will be evaluated by bioimpedance	2 weeks
Secondary	Change from baseline in insulin secretion	The insulin secretion will be evaluated during an oral glucose tolerance test using the oral minimal model	2 weeks
Secondary	Change from baseline in insulin sensitivity	The insulin sensitivity will be evaluated during an oral glucose tolerance test using the oral minimal model	2 weeks