Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorDiabetes Foundation, India
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- CURE-DM
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Diabetes Foundation, India
Lead sponsor
Ministry of Science and Technology, India
Collaborator
Source ClinicalTrials.gov