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Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet

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 re-placers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabaetic medication in intervention group and later comparing it with Control group (on standard medical treatment).
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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.

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Age icon
Age
20 - 84
Gender icon
Gender
All
NCT ID icon
NCT ID
NCT912489
Phase icon
Phase
1
Status icon
Status
Recruiting Now
Medical Condition icon
Medical Condition
Diabetes Mellitus Types I and II

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Medical Condition
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The Study
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About Clinical Trials
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Your Journey

01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.