NCT04363710

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Max Healthcare Insititute Limited · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus in Obese

Interventions

Type	Name	Description
OTHER	Low Calorie Diet	800-1000 Kcal/day

Timeline

• Start date: 2017-05-31
• Primary completion: 2018-06-01
• Completion: 2018-11-07
• First posted: 2020-04-27
• Last updated: 2020-04-27

Locations

1 site across 1 country: India