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

Primary Purpose

PreDiabetes, Obesity, Morbid, Bariatric Surgery Candidate

Status

Active

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Low carbohydrate diet

Energy-matched standard diet

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Prediabetes, Bariatric Surgery, Low-carb diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study intervention

Control intervention

Arm Description

Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks.

Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks.

Outcomes

Primary Outcome Measures

Change from baseline in intrahepatic triglyceride content

The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy

Secondary Outcome Measures

Change from baseline in body weight

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

Change from baseline in liver size

The liver size will be evaluated by magnetic resonance imaging

Change from baseline in visceral adipose tissue

The adipose tissue content will be evaluated by magnetic resonance imaging

Change from baseline in whole body fat mass

Fat mass will be evaluated by bioimpedance

Change from baseline in insulin secretion

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

Change from baseline in insulin sensitivity

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

Full Information

NCT ID

NCT03880162

First Posted

March 7, 2019

Last Updated

July 10, 2023

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT03880162

Brief Title

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

Acronym

CaPrO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes, Obesity, Morbid, Bariatric Surgery Candidate

Keywords

Prediabetes, Bariatric Surgery, Low-carb diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-centre, randomized parallel study

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study intervention

Arm Type

Experimental

Arm Description

Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks.

Arm Title

Control intervention

Arm Type

Active Comparator

Arm Description

Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks.

Intervention Type

Other

Intervention Name(s)

Low carbohydrate diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Energy-matched standard diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in intrahepatic triglyceride content

Description

The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in body weight

Description

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

Time Frame

2 weeks

Title

Change from baseline in liver size

Description

The liver size will be evaluated by magnetic resonance imaging

Time Frame

2 weeks

Title

Change from baseline in visceral adipose tissue

Description

The adipose tissue content will be evaluated by magnetic resonance imaging

Time Frame

2 weeks

Title

Change from baseline in whole body fat mass

Description

Fat mass will be evaluated by bioimpedance

Time Frame

2 weeks

Title

Change from baseline in insulin secretion

Description

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

Time Frame

2 weeks

Title

Change from baseline in insulin sensitivity

Description

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

Time Frame

2 weeks

Other Pre-specified Outcome Measures:

Title

Change from baseline in plasma metabolome

Description

Fasting serum sampling

Time Frame

2 weeks

Title

Change from baseline in plasma transcriptome

Description

Fasting serum sampling

Time Frame

2 weeks

Title

Change from baseline in Fibroblast Growth Factor 21

Description

Plasma level

Time Frame

2 weeks

Title

Change from baseline in adipose tissue inflammation

Description

Adipose tissue histology

Time Frame

2 weeks

Title

Change from baseline in gut microbiota composition

Description

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

Time Frame

2 weeks

Title

Change from baseline levels of secondary bile acids

Description

Faecal sampling

Time Frame

2 weeks

Title

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

Description

Frequency of immune cells will be analysed using flowcytometry

Time Frame

2 weeks

Title

Change in immunometabolism of T-cells

Description

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

Time Frame

2 weeks

Title

Occurrence of surgical complication

Description

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

Time Frame

Day of surgery until 2 weeks post-surgery

Title

Length of hospital stay

Description

Based on medical records

Time Frame

Day of surgery until 2 weeks post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lia Bally, MD PhD

Organizational Affiliation

Inselspital, Bern University Hospital, University of Bern

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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