Health TrialsbyHealthPanel

Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM

ConditionsDiabetes MellitusPreDiabetesDiet Habit
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CURE-DM

    Dietary 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
24 Months

Secondary outcomes

1

Muscle strength

Handgrip muscle strength by Jamar Dynamometer

Time frame
24 Months
2

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)

Time frame
24 Months
3

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).

Time frame
24 Months
4

Body fat

Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan

Time frame
24 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diabetes Foundation, India

Lead sponsor

Ministry of Science and Technology, India

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: