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

Max Healthcare

Status: Completed

Conditions: Type 2 Diabetes Mellitus in Obese

Treatments: Other: Low Calorie Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04363710

RT2DM20

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication

Treatment:

Other: Low Calorie Diet

Control Group

No Intervention group

Description:

Participants in this arm were kept on their standard medical treatment