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

NCT04363710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-04-27

No results posted yet for this study

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

Interventions

OTHER

Low Calorie Diet

800-1000 Kcal/day

Sponsors & Collaborators

  • Max Healthcare Insititute Limited

    lead OTHER

Principal Investigators

  • Sujeet Jha, MRCP · Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2018-06-01
Completion
2018-11-07

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363710 on ClinicalTrials.gov