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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus in Obese

Intervention / Treatment
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* Other: Low Calorie Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication | Other: Low Calorie Diet<br>* 800-1000 Kcal/day<br>|
| No Intervention: Control Group<br>Participants in this arm were kept on their standard medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c in percentage | To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020 | up to 24 weeks | 
| Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR | To achieve normal HOMA IR range | up to 24 weeks | 
| Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2 | when obese T2D individuals will have significant improvement in BMI | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer