PrediabetesVLCBDNCT07830121
Very-Low-Carbohydrate Diet for Prediabetes and Obesity
A study testing Standard Dietary Advice and Very-Low-Carbohydrate Diet (VLCBD) in people with Prediabetes and Obesity / Overweight, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Prediabetes, Obesity / Overweight, VERY LOW CARBOHYDRATE DIET
- What is being tested?
- Standard Dietary Advice and Very-Low-Carbohydrate Diet (VLCBD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2024to 1 Dec 2025
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of type 1 or type 2 diabetes mellitus
- Calculated creatinine clearance <60 mL/min/1.73 m²
- on antiobesity medications
- On medications that can interfere with glucose metabolism
- Heart failure, New York Heart Association (NYHA) functional class III-IV
- Active systemic inflammatory disease
Show all 13Show fewer
- Chronic kidney disease requiring haemodialysis
- Active hepatic disease
- Collagen vascular disease
- Malignancy
- Acute coronary syndrome within the preceding 3 months
- Pregnancy or breastfeeding
- Plans to conceive within the following year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Standard Dietary Advice, Very-Low-Carbohydrate Diet (VLCBD)
- Keywords
- PREDIABETES, OBESITY, OVERWEIGHT, Low-carbohydrate diet, Very-low-carbohydrate diet, Randomised controlled trial, Insulin resistance, Weight loss, Body composition
- Medical subject headings
- Prediabetic State, Obesity, Overweight, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dietary AdviceBehavioural
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.
Very-Low-Carbohydrate Diet (VLCBD)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dietary Advice | Active comparator | 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. Receives: Behavioral: Standard Dietary Advice |
| Very-Low-Carbohydrate Diet (VLCBD) | Experimental | 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. Receives: Behavioral: Very-Low-Carbohydrate Diet (VLCBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel arms - a very-low-carbohydrate diet (VLCBD) or standard dietary advice - and followed concurrently for 12 weeks. The study was open-label, as blinding participants to their assigned diet was not feasible.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohana Abdul Ghani, Universiti Teknologi Mara
- Investigators
- Rohana Abdul Ghani, Medical degree, Study chair, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830121
- Sponsor's protocol ID
- NABMuhammadZawawi
- Acronym
- VLCBD
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez-Arbelaez D, Bellido D, Castro AI, Ordonez-Mayan L, Carreira J, Galban C, Martinez-Olmos MA, Crujeiras AB, Sajoux I, Casanueva FF. Body Composition Changes After Very-Low-Calorie Ketogenic Diet in Obesity Evaluated by 3 Standardized Methods. J Clin Endocrinol Metab. 2017 Feb 1;102(2):488-498. doi: 10.1210/jc.2016-2385.
PubMed 27754807Zainordin NA, Eddy Warman NA, Mohamad AF, Abu Yazid FA, Ismail NH, Chen XW, Koshy M, Abdul Rahman TH, Mohd Ismail N, Abdul Ghani R. Safety and efficacy of very low carbohydrate diet in patients with diabetic kidney disease-A randomized controlled trial. PLoS One. 2021 Oct 13;16(10):e0258507. doi: 10.1371/journal.pone.0258507. eCollection 2021.
PubMed 34644368Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Morris E, Aveyard P, Dyson P, Noreik M, Bailey C, Fox R, Jerome D, Tan GD, Jebb SA. A food-based, low-energy, low-carbohydrate diet for people with type 2 diabetes in primary care: A randomized controlled feasibility trial. Diabetes Obes Metab. 2020 Apr;22(4):512-520. doi: 10.1111/dom.13915. Epub 2019 Nov 25.
PubMed 31709697Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
PubMed 30852132Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07830121
- Acronym / sponsor ID
- VLCBD / NABMuhammadZawawi
- Keywords
- PREDIABETES, OBESITY, OVERWEIGHT, Low-carbohydrate diet, Very-low-carbohydrate diet, Randomised controlled trial, Insulin resistance, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel arms - a very-low-carbohydrate diet (VLCBD) or standard dietary advice - and followed concurrently for 12 weeks. The study was open-label, as blinding participants to their assigned diet was not feasible.
| Arm | Type | Receives |
|---|---|---|
| Standard Dietary Advice | Active comparator | Behavioral: Standard Dietary AdviceParticipants 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. |
| Very-Low-Carbohydrate Diet (VLCBD) | Experimental | Behavioral: Very-Low-Carbohydrate Diet (VLCBD)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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Diagnosis of type 1 or type 2 diabetes mellitus
- Calculated creatinine clearance <60 mL/min/1.73 m²
- on antiobesity medications
- On medications that can interfere with glucose metabolism
- Heart failure, New York Heart Association (NYHA) functional class III-IV
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 |
|---|---|---|
| Standard Dietary AdviceParticipants 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. | Behavioural | Standard Dietary Advice |
| Very-Low-Carbohydrate Diet (VLCBD)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. | Behavioural | Very-Low-Carbohydrate Diet (VLCBD) |
Primary outcome
Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Body weight was measured in kilograms (kg) using a calibrated digital scale, with participants in light clothing and without shoes.
Change From Baseline in Body Mass Index (BMI) at Week 12
Time frame: Baseline and Week 12
BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).
Change From Baseline in Waist Circumference at Week 12
Time frame: Baseline and Week 12
Waist circumference was measured in centimetres (cm) at the midpoint between the lowest rib and the iliac crest.
Change From Baseline in Body Fat Percentage at Week 12
Time frame: Baseline and Week 12
Body fat percentage was measured using bioelectrical impedance analysis expressed as a percentage of total body weight.
3 secondary outcomes
Change in HOMA-IR
Time frame: Baseline and week 12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
Time frame: Baseline and Week 12
Participant Retention Rate at Week 12
Time frame: Baseline and Week 12
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 21 Sep 2026.
- Background: PubMed 27754807Gomez-Arbelaez D, Bellido D, Castro AI, Ordonez-Mayan L, Carreira J, Galban C, Martinez-Olmos MA, Crujeiras AB, Sajoux I, Casanueva FF. Body Composition Changes After Very-Low-Calorie Ketogenic Diet in Obesity Evaluated by 3 Standardized Methods. J Clin Endocrinol Metab. 2017 Feb 1;102(2):488-498. doi: 10.1210/jc.2016-2385.
- Results publication: PubMed 34644368Zainordin NA, Eddy Warman NA, Mohamad AF, Abu Yazid FA, Ismail NH, Chen XW, Koshy M, Abdul Rahman TH, Mohd Ismail N, Abdul Ghani R. Safety and efficacy of very low carbohydrate diet in patients with diabetic kidney disease-A randomized controlled trial. PLoS One. 2021 Oct 13;16(10):e0258507. doi: 10.1371/journal.pone.0258507. eCollection 2021.
- Results publication: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Results publication: PubMed 31709697Morris E, Aveyard P, Dyson P, Noreik M, Bailey C, Fox R, Jerome D, Tan GD, Jebb SA. A food-based, low-energy, low-carbohydrate diet for people with type 2 diabetes in primary care: A randomized controlled feasibility trial. Diabetes Obes Metab. 2020 Apr;22(4):512-520. doi: 10.1111/dom.13915. Epub 2019 Nov 25.
- Results publication: PubMed 30852132Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
- Results publication: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- Zainordin et al. (2021) - the randomized controlled trial whose weight-change effect size was used to calculate this study's sample size, and whose renal safety findings this study's safety results are compared against.Link provided by the sponsor.
- Lean et al. (2018) - the DiRECT trial, a primary care-led weight-management RCT for type 2 diabetes remission, cited for comparison of weight-loss outcomes.Link provided by the sponsor.
- Lean et al. (2019) - 2-year follow-up results of the DiRECT trial, cited for the ≥15 kg weight-loss threshold data used in this study's comparison table.Link provided by the sponsor.
- Morris et al. (2020) - the DIAMOND trial, a randomized feasibility trial of a low-energy, low-carbohydrate diet in type 2 diabetes, cited for comparison of dietary intervention design and HOMA-IR outcomes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rohana Abdul Ghani, Medical degree study chair
Universiti Teknologi Mara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dietary Advice and Very-Low-Carbohydrate Diet (VLCBD) in people with Prediabetes and Obesity / Overweight, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 5 inclusion and 13 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 21 Sep 2026. 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 Malaysia. 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 Body Weight at Week 12 (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830121, which also lists 6 linked publications.
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 21 Sep 2026.