NCT03880162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

March 7, 2019

Last Update Submit

December 4, 2024

Conditions

PreDiabetesObesity, MorbidBariatric Surgery Candidate

Keywords

PrediabetesBariatric SurgeryLow-carb diet

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in intrahepatic triglyceride content

    The intrahepatic triglyceride content will be evaluated by magnetic resonance spectroscopy

    2 weeks

Secondary Outcomes (6)

  • Change from baseline in body weight

    2 weeks

  • Change from baseline in liver size

    2 weeks

  • Change from baseline in visceral adipose tissue

    2 weeks

  • Change from baseline in whole body fat mass

    2 weeks

  • Change from baseline in insulin secretion

    2 weeks

  • +1 more secondary outcomes

Other Outcomes (10)

  • Change from baseline in plasma metabolome

    2 weeks

  • Change from baseline in plasma transcriptome

    2 weeks

  • Change from baseline in Fibroblast Growth Factor 21

    2 weeks

  • +7 more other outcomes

Study Arms (2)

Study intervention

EXPERIMENTAL

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

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.

Other: Energy-matched standard diet

Interventions

Low carbohydrate dietOTHER

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

Study intervention
Energy-matched standard dietOTHER

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

Control intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Prediabetic StateObesity, Morbid

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Lia Bally, MD PhD

    Inselspital, Bern University Hospital, University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-centre, randomized parallel study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 19, 2019

Study Start

May 13, 2019

Primary Completion

May 3, 2024

Study Completion

May 3, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations

CH(1)