Type 2 Diabetes Mellitus in Obese
Conditions
Keywords
Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
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.
Interventions
OTHERLow Calorie Diet
800-1000 Kcal/day
Sponsors
Max Healthcare Insititute Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c in percentage | up to 24 weeks | To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020 |
| Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR | up to 24 weeks | To achieve normal HOMA IR range |
| Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2 | up to 24 weeks | when obese T2D individuals will have significant improvement in BMI |
Countries
India
Outcome results
None listed