Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
Study Overview
Brief Summary
T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of < 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 - 800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabetic medication in intervention group and later comparing it with Control group (on standard medical treatment).
Detailed Description
The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.
Purposive sampling is used to enroll participants in the study. The LCD is a combination of one meal replacer and modified major meals. Calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. Inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400 Kcal/day. In the control group the standard medical treatment is continued.
The data is collected in case report form and analysed using SPSS software by statistician.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with BMI ≥ 30 kg/m^2
- •DM history of less than 6 years.
- •HBA1C of 6.5-8.5 %.
- •On two or less than two diabetes medication.
Exclusion Criteria
- •Patients on Insulin
- •Patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness.
- •Evidence of Type 1 diabetes, ketones and acidosis.
Arms & Interventions
Intervention group
Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication
Intervention: Low Calorie Diet (Other)
Control Group
Participants in this arm were kept on their standard medical treatment
Outcomes
Primary Outcomes
Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
Time Frame: up to 24 weeks
To achieve normal HOMA IR range
HbA1c in percentage
Time Frame: up to 24 weeks
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
Time Frame: up to 24 weeks
when obese T2D individuals will have significant improvement in BMI
Secondary Outcomes
No secondary outcomes reported