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

Type 2 Diabetes Mellitus in Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363710
• Other study ID #: RT2DM20
• Status: Completed
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: April 2020
• Source: Max Healthcare Insititute Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 7, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus in Obese

Intervention

Other:
• Low Calorie Diet
800-1000 Kcal/day

Locations

Country	Name	City	State
India	Max Healthcare	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c in percentage	To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020	up to 24 weeks
Primary	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
Primary	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