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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 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Change from baseline in intrahepatic triglyceride content [ Time Frame: 2 weeks ]
The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Change from baseline in body weight [ Time Frame: 2 weeks ]
    The body weight will be measured using a pre-defined person scale
  • Change from baseline in liver size [ Time Frame: 2 weeks ]
    The liver size will be evaluated by magnetic resonance imaging
  • Change from baseline in visceral adipose tissue [ Time Frame: 2 weeks ]
    The adipose tissue content will be evaluated by magnetic resonance imaging
  • Change from baseline in whole body fat mass [ Time Frame: 2 weeks ]
    Fat mass will be evaluated by bioimpedance
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 15, 2019)
  • Change from baseline in plasma metabolome [ Time Frame: 2 weeks ]
    Fasting serum sampling
  • Change from baseline in plasma transcriptome [ Time Frame: 2 weeks ]
    Fasting serum sampling
  • Change from baseline in Fibroblast Growth Factor 21 [ Time Frame: 2 weeks ]
    Plasma level
  • Change from baseline in adipose tissue inflammation [ Time Frame: 2 weeks ]
    Adipose tissue histology
  • 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
  • Change from baseline levels of secondary bile acids [ Time Frame: 2 weeks ]
    Faecal sampling
  • 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
  • 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
  • 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)
  • Length of hospital stay [ Time Frame: Day of surgery until 2 weeks post-surgery ]
    Based on medical records
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes
Official Title  ICMJE Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single-centre, randomized parallel study
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • PreDiabetes
  • Obesity, Morbid
  • Bariatric Surgery Candidate
Intervention  ICMJE
  • Other: Low carbohydrate diet
    A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)
  • Other: Energy-matched standard diet
    Energy-matched (30% deficit) standard diet (50% of carbohydrates)
Study Arms  ICMJE
  • Experimental: Study intervention
    Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks.
    Intervention: Other: Low carbohydrate diet
  • Active Comparator: Control intervention
    Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks.
    Intervention: Other: Energy-matched standard diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lia Bally, MD PhD +41 (0)31 632 36 77 lia.bally@insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880162
Other Study ID Numbers  ICMJE CaPrO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lia Bally, MD PhD Inselspital, Bern University Hospital, University of Bern
PRS Account University Hospital Inselspital, Berne
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP