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 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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus in Obese
• Intervention / Treatment: Other: Low Calorie Diet

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110017
      • max healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Low Calorie Diet; 800-1000 Kcal/day
No Intervention: Control Group; Participants in this arm were kept on their standard medical treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Max Healthcare Insititute Limited
• Investigators: Principal Investigator: Sujeet Jha, MRCP, Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RT2DM20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No