An interventional study of Standard Dietary Advice and Very-Low-Carbohydrate Diet (VLCBD) in Prediabetes, Obesity / Overweight and VERY LOW CARBOHYDRATE DIET, sponsored by Universiti Teknologi Mara. Completed at 1 site in Malaysia. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Universiti Teknologi Mara · Not applicable, Interventional, and Prevention
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.
Obesity and prediabetes frequently coexist and share a common pathophysiological pathway: excess visceral adiposity promotes chronic low-grade inflammation and insulin resistance, accelerating progression from normoglycaemia to prediabetes and ultimately to type 2 diabetes mellitus (T2DM). While carbohydrate-restricted dietary interventions have demonstrated efficacy for weight loss and glycaemic improvement in patients with established T2DM and diabetic kidney disease, their effects have not been well characterised in the earlier, potentially reversible stage of prediabetes, where intervention may carry the greatest preventive value.
This single-centre, randomized controlled trial evaluates the effects of a 12-week very-low-carbohydrate diet (VLCBD, less than 50 g carbohydrate/day) compared with standard dietary advice (no specific carbohydrate restriction) in adults with obesity and prediabetes attending a tertiary endocrine outpatient clinic in Malaysia. Both study arms receive individualised caloric intake based on ideal body weight, structured dietary counselling, and food diaries for adherence monitoring.
The study compares the two dietary approaches with respect to anthropometric and body composition changes, insulin resistance, and the safety and feasibility of the VLCBD approach over the 12-week intervention period, with assessments at baseline and at Week 12. Findings are intended to inform whether carbohydrate restriction is a feasible, safe, and effective dietary strategy for reducing cardiometabolic risk and preventing progression to type 2 diabetes in adults with prediabetes and obesity - a population not directly addressed by prior low-carbohydrate diet trials, which have been conducted mainly in patients with established diabetes.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's enrollment of 33 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Universiti Teknologi Mara is the lead sponsor of 26 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received standard dietary advice with no specific carbohydrate restriction, with total caloric intake individualised to ideal body weight, the same dietitian counselling, and food diaries, for 12 weeks.
Behavioral: Standard Dietary Advice
Participants received a very-low-carbohydrate diet (\<50 g carbohydrate/day), with total caloric intake individualised to ideal body weight, structured dietitian counselling, and food diaries, for 12 weeks.
Behavioral: Very-Low-Carbohydrate Diet (VLCBD)
Participants received standard dietary advice with no specific carbohydrate restriction, with total caloric intake individualised to ideal body weight, the same dietitian counselling, and food diaries, for 12 weeks.
Participants received a very-low-carbohydrate diet (\<50 g carbohydrate/day), with total caloric intake individualised to ideal body weight, structured dietitian counselling, and food diaries, for 12 weeks.
Change From Baseline in Body Weight at Week 12
Body weight was measured in kilograms (kg) using a calibrated digital scale, with participants in light clothing and without shoes.
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index (BMI) at Week 12
BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline and Week 12
Change From Baseline in Waist Circumference at Week 12
Waist circumference was measured in centimetres (cm) at the midpoint between the lowest rib and the iliac crest.
Time frame: Baseline and Week 12
Change From Baseline in Body Fat Percentage at Week 12
Body fat percentage was measured using bioelectrical impedance analysis expressed as a percentage of total body weight.
Time frame: Baseline and Week 12
Change in HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as fasting insulin (mU/L) × fasting glucose (mmol/L) ÷ 22.5, was compared between arms from baseline to Week 12 to assess insulin resistance.
Time frame: Baseline and week 12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
eGFR was calculated from serum creatinine using the CKD-EPI formula, expressed in mL/min/1.73m²
Time frame: Baseline and Week 12
Participant Retention Rate at Week 12
Retention rate was defined as the number of participants completing the Week 12 assessment divided by the number randomized, expressed as a percentage
Time frame: Baseline and Week 12
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2024 to primary completion in Dec 2025, 23 months.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 23 months is close to that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Universiti Teknologi Mara