NCT05925946

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
6mo left

Started Oct 2023

Typical duration for not_applicable diabetes-mellitus

Status
not yet recruiting

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

Study Progress84%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

June 13, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

June 13, 2023

Last Update Submit

June 22, 2023

Conditions

Diabetes MellitusPreDiabetesDiet Habit

Keywords

Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 Months

Secondary Outcomes (5)

  • Muscle strength

    24 Months

  • Anthropometric assessment

    24 Months

  • Hepatic and Pancreatic Fat

    24 Months

  • Body fat

    24 Months

  • Insulin Resistance

    24 Months

Study Arms (2)

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) :

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.

Interventions

CURE-DMDIETARY_SUPPLEMENT

1. 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.

Intervention Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateFeeding BehaviorDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Central Study Contacts

Anoop Misra, MD

CONTACT

01141759672anoopmisra@gmail.com

Surya Prakash, PhD+Post Doc

CONTACT

01141759672suryabhat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 29, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

June 29, 2023

Record last verified: 2023-06