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Completed

NCT Number: NCT03880162

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

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

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Key information

Conditions

PreDiabetes Bariatric Surgery Candidate Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low carbohydrate diet

Other

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

Energy-matched standard diet

Other

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

Primary outcomes

  1. Change from baseline in intrahepatic triglyceride content

    Time frame: 2 weeks

    The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: 2 weeks

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

  2. Change from baseline in liver size

    Time frame: 2 weeks

    The liver size will be evaluated by magnetic resonance imaging

  3. Change from baseline in visceral adipose tissue

    Time frame: 2 weeks

    The adipose tissue content will be evaluated by magnetic resonance imaging

  4. Change from baseline in whole body fat mass

    Time frame: 2 weeks

    Fat mass will be evaluated by bioimpedance

  5. Change from baseline in insulin secretion

    Time frame: 2 weeks

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

  6. Change from baseline in insulin sensitivity

    Time frame: 2 weeks

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

Other outcomes

  1. Change from baseline in plasma metabolome

    Time frame: 2 weeks

    Fasting serum sampling

  2. Change from baseline in plasma transcriptome

    Time frame: 2 weeks

    Fasting serum sampling

  3. Change from baseline in Fibroblast Growth Factor 21

    Time frame: 2 weeks

    Plasma level

  4. Change from baseline in adipose tissue inflammation

    Time frame: 2 weeks

    Adipose tissue histology

  5. Change from baseline in gut microbiota composition

    Time frame: 2 weeks

    Distribution of the predominant bacterial phylotypes will be assessed after 16S rRNA amplicon sequencing and subsequent taxonomic classification

  6. Change from baseline levels of secondary bile acids

    Time frame: 2 weeks

    Faecal sampling

  7. Change in frequency of immune cells (T-, B-, NK-cells, monocytes, neutrophils)

    Time frame: 2 weeks

    Frequency of immune cells will be analysed using flowcytometry

  8. Change in immunometabolism of T-cells

    Time frame: 2 weeks

    Immunometabolism will be assessed by quantifying rates of oxygen consumption and glycolysis using metabolic flux analysis

  9. Occurrence of surgical complication

    Time frame: Day of surgery until 2 weeks post-surgery

    Occurrence of the following: anastomotic leak, infection, bleeding, deep venous thrombosis (based on medical records)

  10. Length of hospital stay

    Time frame: Day of surgery until 2 weeks post-surgery

    Based on medical records

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: CaPrO

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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