Diabetes MellitusCURE-DMNCT05925946
Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM
A study testing CURE-DM in people with Diabetes Mellitus and PreDiabetes, run by Diabetes Foundation, India.
Trial summary
An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, PreDiabetes, Diet Habit
- What is being tested?
- CURE-DM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Oct 2026
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with T2DM within the previous 3 years
- Age 20-65 years
- BMI >25-45kg/m2
- HbA1c> 6.5% at baseline (on current treatment, if any)
Who cannot join
- Recent or screening HbA1c of 9% or higher
- Weight loss of >5 kg within the previous 6 months
- Significant cardiopulmonary
- Hepatic, or another endocrine disease
- Current participation in any other research drug study in the previous three months
- Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of Type 2 Diabetes Mellitus, Hepatic and Pancreatic Fat: A Two-year Randomized Control Trial in New Delhi, India
An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.
Read the detailed description
Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.
- Conditions
- Diabetes Mellitus, PreDiabetes, Diet Habit
- Being tested
- CURE-DM
- Keywords
- Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Feeding Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURE-DMDietary supplement
- This randomized controlled prospective trial will be of 2 years duration where 150 patients with T2DM from urban areas of Delhi will be screened.
- These subjects will be randomized into two groups by computer-generated randomization list using variable block size.
- Group A (n, 60, test group)will be received a low-calorie diet along with appropriate exercise counseling; and group B (n, 60, Control group) will be received balanced diet along with exercise advice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 1. Phase1 (Partial diet replacement) (850 Kcal/day) (12-20 weeks)):
2. Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal/day):
3. Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal/day) : Receives: Dietary Supplement: CURE-DM |
| Control Group | No intervention | Subjects will be given routine care for diabetes and obesity management with no change in medication. The meal plan for the control group will consist of 1400 Kcal/day achieved through small frequently distributed meals constituting around 15% of protein, 60% of carbohydrates and 25% of fat; with a menu resembling standard Indian dietary patterns and meal combinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of diabetes
This randomized controlled prospective trial will be of 2 years duration with T2D. These subjects will be randomized into two groups, Group A (intervention group) will receive a professionally supported low-calorie diet along with appropriate exercise counselling; Group B (Control group) will be receiving encouragement to follow standard diet and exercise advice.
Measured: 24 Months
Secondary outcomes (5)
Muscle strength
Handgrip muscle strength by Jamar Dynamometer
Measured: 24 Months
Anthropometric assessment
Weight, BMI, circumferences (waist, hip, mid-thigh, mid-arm and neck), skinfold thickness (biceps, triceps, sub scapular, supra-iliac, thigh, lateral thoracic and calf)
Measured: 24 Months
Hepatic and Pancreatic Fat
Liver and pancreatic fat fraction (proton-density fat fraction-magnetic resonance imaging (PDFF-MRI) and thigh skeletal muscle area (by MRI).
Measured: 24 Months
Body fat
Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan
Measured: 24 Months
Insulin Resistance
Surrogate markers of insulin sensitivity
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925946
- Sponsor's protocol ID
- 2022-1312
- Acronym
- CURE-DM
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This randomized controlled prospective trial will be of 2 years duration
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of Type 2 Diabetes Mellitus, Hepatic and Pancreatic Fat: A Two-year Randomized Control Trial in New Delhi, India
- ClinicalTrials.gov ID
- NCT05925946
- Acronym / sponsor ID
- CURE-DM / 2022-1312
- Conditions
- Diabetes Mellitus, PreDiabetes, Diet Habit
- Keywords
- Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Jun 2023 (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.
An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.
Detailed description
Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: CURE-DM1. Phase1 (Partial diet replacement) (850 Kcal/day) (12-20 weeks)): 2. Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal/day): 3. Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal/day) : |
| Control Group | No intervention | –Subjects will be given routine care for diabetes and obesity management with no change in medication. The meal plan for the control group will consist of 1400 Kcal/day achieved through small frequently distributed meals constituting around 15% of protein, 60% of carbohydrates and 25% of fat; with a menu resembling standard Indian dietary patterns and meal combinations. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with T2DM within the previous 3 years
- Age 20-65 years
- BMI >25-45kg/m2
- HbA1c> 6.5% at baseline (on current treatment, if any)
Key exclusion criteria (6 listed)
- Recent or screening HbA1c of 9% or higher
- Weight loss of >5 kg within the previous 6 months
- Significant cardiopulmonary
- Hepatic, or another endocrine disease
- Current participation in any other research drug study in the previous three months
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 |
|---|---|---|
| CURE-DM1. This randomized controlled prospective trial will be of 2 years duration where 150 patients with T2DM from urban areas of Delhi will be screened. 2. These subjects will be randomized into two groups by computer-generated randomization list using variable block size. 3. Group A (n, 60, test group)will be received a low-calorie diet along with appropriate exercise counseling; and group B (n, 60, Control group) will be received balanced diet along with exercise advice. | Dietary supplement | Intervention Group |
Primary outcome
Reversal of diabetes
Time frame: 24 Months
This randomized controlled prospective trial will be of 2 years duration with T2D. These subjects will be randomized into two groups, Group A (intervention group) will receive a professionally supported low-calorie diet along with appropriate exercise counselling; Group B (Control group) will be receiving encouragement to follow standard diet and exercise advice.
5 secondary outcomes
Muscle strength
Time frame: 24 Months
Anthropometric assessment
Time frame: 24 Months
Hepatic and Pancreatic Fat
Time frame: 24 Months
Body fat
Time frame: 24 Months
Insulin Resistance
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: Undecided. This randomized controlled prospective trial will be of 2 years duration
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CURE-DM in people with Diabetes Mellitus and PreDiabetes, run by Diabetes Foundation, India.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01141759672, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of diabetes (time frame: 24 Months). 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 29 Jun 2023.