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Completed

NCT Number: NCT04363710

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).

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Key information

Conditions

Type 2 Diabetes Mellitus in Obese Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Healthcare

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low calorie diet

Other

800-1000 Kcal/day

Primary outcomes

  1. HbA1c in percentage

    Time frame: up to 24 weeks

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

  2. Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR

    Time frame: up to 24 weeks

    To achieve normal HOMA IR range

  3. Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2

    Time frame: up to 24 weeks

    when obese T2D individuals will have significant improvement in BMI

Sponsors and collaborators

Lead sponsor

Max Healthcare Insititute Limited

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2020
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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