NCT07830121Completed
Very-Low-Carbohydrate Diet for Prediabetes and Obesity
Effects of a 12-Week Very-Low-Carbohydrate Diet on Body Composition and Cardiometabolic Outcomes in Adults With Prediabetes and Obesity: A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
Prediabetes is a condition where blood sugar is higher than normal but not yet high enough to be called type 2 diabetes. It is common in adults who are overweight or obese, and without treatment it often progresses to diabetes over time. This study looks at whether following a very-low-carbohydrate diet for 12 weeks can help adults with prediabetes and obesity lose weight, reduce body fat, and improve how well their body responds to insulin, compared with standard dietary advice. Adults aged 30 to 65 with obesity and newly diagnosed prediabetes are invited to take part. Participants are randomly assigned to one of two groups: one follows a very-low-carbohydrate diet with support from a dietitian, and the other receives standard dietary advice without a specific carbohydrate limit. Both groups are followed for 12 weeks, during which their weight, body composition, blood sugar, insulin levels, cholesterol, and kidney function are checked. The study aims to find out whether the very-low-carbohydrate diet leads to greater improvements in weight, body fat, and insulin sensitivity than standard advice, and whether it is safe and practical to follow in everyday life. The findings may help doctors and dietitians offer more effective ways to prevent prediabetes from progressing to type 2 diabetes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 1 Sept 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Universiti Teknologi Mara
- Diseases
- Obesity
- NCT number
- NCT07830121
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 1 Jan 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- on antiobesity medications
Other illness
- Diagnosis of type 1 or type 2 diabetes mellitus
- Heart failure, New York Heart Association (NYHA) functional class III-IV
- Active systemic inflammatory disease
- Chronic kidney disease requiring haemodialysis
- Active hepatic disease
- Collagen vascular disease
- Malignancy
- Acute coronary syndrome within the preceding 3 months
Lab values
- Calculated creatinine clearance \<60 mL/min/1.73 m²
- On medications that can interfere with glucose metabolism
Other
- Pregnancy or breastfeeding
- Plans to conceive within the following year
Who the study is looking for
- Age 30 to 65 years
- Body mass index (BMI) 23-40 kg/m²
- Diagnosis of prediabetes, defined as fasting blood glucose (FBG) 5.6-6.9 mmol/L or glycated haemoglobin (HbA1c) 5.6-6.2%
- Able to stand independently
- Able to provide written informed consent
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital UITM Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.