Skip to content

Retrospective analysis to see the effect of Freedom from diabetes protocol on management of prediabetes/type 2 diabetes/obesity in India

A Retrospective Analysis to Assess the Effect of an Integrated Intensive Lifestyle Intervention among Individuals with Prediabetes /Type 2 Diabetes/Obesity in India - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064596
Enrollment
20000
Registered
2024-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Sponsors

Freedom from diabetes research foundation (Host Institution)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 75 years 2. Confirmed diagnosis of prediabetes or type 2 diabetes and/or BMI more than 23 kg/m2

Exclusion criteria

Exclusion criteria: 1. Diabetes type other than type 2 like LADA, MODY, gestational 2. Those with complete data

Design outcomes

Primary

MeasureTime frame
1.At least 10% reduction in weight at one year & HbA1c less than 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year. 2. BMI below 23 or least 3 point drop 3. Reduction in mental health scores to below 10 4. At least 10% improvement in lipid levels Timepoint: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year Mental health questionnaire at baseline and at 6 months

Secondary

MeasureTime frame
Improvement in other biochemical parameters like serum creatinine, eGFR, SGPT, SGOT, urine microalbumiuria, C-reactive protein.Timepoint: Biochemical parameters will be assessed at baseline, 6 months and at 1 year

Countries

India

Contacts

Public ContactDr Nidhi Kadam

Freedom From Diabetes Research Foundation

kadam.nidhi@gmail.com9822792772

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026