PreDiabetesCaPrONCT03880162
Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes
A study testing Low carbohydrate diet and Energy-matched standard diet in people with PreDiabetes and Obesity, Morbid, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- Low carbohydrate diet and Energy-matched standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 May 2019to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
Bern, 3010
About this study
Official title: Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals 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.
Read the 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.
- Conditions
- PreDiabetes, Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- Low carbohydrate diet, Energy-matched standard diet
- Keywords
- Prediabetes, Bariatric Surgery, Low-carb diet
- Medical subject headings
- Prediabetic State, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)
Energy-matched standard dietOther
Energy-matched (30% deficit) standard diet (50% of carbohydrates)
| Study group | Role | What they receive |
|---|---|---|
| Study intervention | Experimental | Participants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks. Receives: Other: Low carbohydrate diet |
| Control intervention | Active comparator | Participants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks. Receives: Other: Energy-matched standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intrahepatic triglyceride content
The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy
Measured: 2 weeks
Secondary outcomes (6)
Change from baseline in body weight
The body weight will be measured using a pre-defined person scale
Measured: 2 weeks
Change from baseline in liver size
The liver size will be evaluated by magnetic resonance imaging
Measured: 2 weeks
Change from baseline in visceral adipose tissue
The adipose tissue content will be evaluated by magnetic resonance imaging
Measured: 2 weeks
Change from baseline in whole body fat mass
Fat mass will be evaluated by bioimpedance
Measured: 2 weeks
Change from baseline in insulin secretion
The insulin secretion will be evaluated during an oral glucose tolerance test using the oral minimal model
Measured: 2 weeks
Change from baseline in insulin sensitivity
The insulin sensitivity will be evaluated during an oral glucose tolerance test using the oral minimal model
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start13 May 2019
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, randomized parallel study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lia Bally, MD PhD, Principal investigator, Inselspital, Bern University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880162
- Sponsor's protocol ID
- CaPrO
- Acronym
- CaPrO
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of a Low Carbohydrate Versus Energy-matched Standard Diet in Morbidly Obese Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT03880162
- Acronym / sponsor ID
- CaPrO / CaPrO
- Conditions
- PreDiabetes, Obesity, Morbid, Bariatric Surgery Candidate
- Keywords
- Prediabetes, Bariatric Surgery, Low-carb diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-centre, randomized parallel study
| Arm | Type | Receives |
|---|---|---|
| Study intervention | Experimental | Other: Low carbohydrate dietParticipants will follow an energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) for minimum two weeks. |
| Control intervention | Active comparator | Other: Energy-matched standard dietParticipants will follow an energy deficient (30% deficit) standard diet (50% of carbohydrates) for minimum two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietA energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates) | Other | Study intervention |
| Energy-matched standard dietEnergy-matched (30% deficit) standard diet (50% of carbohydrates) | Other | Control intervention |
Primary outcome
Change from baseline in intrahepatic triglyceride content
Time frame: 2 weeks
The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy
6 secondary outcomes
Change from baseline in body weight
Time frame: 2 weeks
Change from baseline in liver size
Time frame: 2 weeks
Change from baseline in visceral adipose tissue
Time frame: 2 weeks
Change from baseline in whole body fat mass
Time frame: 2 weeks
Change from baseline in insulin secretion
Time frame: 2 weeks
Change from baseline in insulin sensitivity
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD PhD principal investigator
Inselspital, Bern University Hospital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet and Energy-matched standard diet in people with PreDiabetes and Obesity, Morbid, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in intrahepatic triglyceride content (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.