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

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ClinicalTrials.gov Identifier: NCT03880162
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Obesity, Morbid Bariatric Surgery Candidate Other: Low carbohydrate diet Other: Energy-matched standard diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, randomized parallel study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study intervention
Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks.
Other: Low carbohydrate diet
A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)

Active Comparator: Control intervention
Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks.
Other: Energy-matched standard diet
Energy-matched (30% deficit) standard diet (50% of carbohydrates)




Primary Outcome Measures :
  1. Change from baseline in intrahepatic triglyceride content [ Time Frame: 2 weeks ]
    The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880162


Contacts
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Contact: Lia Bally, MD PhD +41 (0)31 632 36 77 lia.bally@insel.ch

Locations
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Switzerland
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Lia Bally, MD PhD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lia Bally, MD PhD Inselspital, Bern University Hospital, University of Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03880162     History of Changes
Other Study ID Numbers: CaPrO
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Prediabetes
Bariatric Surgery
Low-carb diet
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Obesity, Morbid
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms