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

Primary Purpose

Type 2 Diabetes Mellitus in Obese

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Low Calorie Diet
Sponsored by
Max Healthcare Insititute Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus in Obese focused on measuring Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Max Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm Description

Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication

Participants in this arm were kept on their standard medical treatment

Outcomes

Primary Outcome Measures

HbA1c in percentage
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
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
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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2020
Last Updated
April 24, 2020
Sponsor
Max Healthcare Insititute Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04363710
Brief Title
Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
Official Title
Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Healthcare Insititute Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus in Obese
Keywords
Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this arm were kept on their standard medical treatment
Intervention Type
Other
Intervention Name(s)
Low Calorie Diet
Intervention Description
800-1000 Kcal/day
Primary Outcome Measure Information:
Title
HbA1c in percentage
Description
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
Time Frame
up to 24 weeks
Title
Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
Description
To achieve normal HOMA IR range
Time Frame
up to 24 weeks
Title
Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
Description
when obese T2D individuals will have significant improvement in BMI
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujeet Jha, MRCP
Organizational Affiliation
Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Healthcare
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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