Clinical trial NCT04363710: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus in Obese
Keywords: Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 33
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: HbA1c in percentage
timeFrame: up to 24 weeks
measure: Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
timeFrame: up to 24 weeks
measure: Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Healthcare
state: Delhi
Study officials:
affiliation: Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare
name: Sujeet Jha, MRCP
role: PRINCIPAL_INVESTIGATOR
References: