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

NCT04363710 | Completed

• 1 other identifier: RT2DM20
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus in Obese

Keywords

Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in this arm were kept on their standard medical treatment

Interventions

Low Calorie Diet OTHER

800-1000 Kcal/day

Intervention group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Max Healthcare Insititute Limited: lead

Study Sites (1)

Max Healthcare

New Delhi, National Capital Territory of Delhi, 110017, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sujeet Jha, MRCP

  Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 27, 2020
• Study Start: May 31, 2017
• Primary Completion: June 1, 2018
• Study Completion: November 7, 2018
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)