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Effect of Freedom From Diabetes Protocol on improvement in Anxiety and Depression in patients with Type 2 diabetes in India

Mental Health Outcomes in Patients with Type 2 Diabetes Enrolled for the Diabetes Remission Study in India (DiRemI) - DiRemI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060861
Enrollment
300
Registered
2023-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Intervention1: Lifestyle modification: The duration of the intervention is 6 months, with a 6-month follow-up post intervention. The intervention will consist of a Plant-based diet, Physical activity

Sponsors

Freedom from diabetes research foundation (Host Institution)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Confirmed diagnosis of Type 2 Diabetes 2) Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation 3)Participants who are well-oriented in time, and space & as a person 4)Provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). 2) Gestational Diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation). 3)Specific types of diabetes due to other causes, eg., monogenic diabetes syndromes, diseases of exocrine pancreas, drug or chemical induced diabetes 4) Pregnant or lactating women 5) Patients who have required hospitalization for any diabetes-related complications in the last 6 months or for depression or are on antipsychotic drugs.

Design outcomes

Primary

MeasureTime frame
Improvement in Mental Health outcomesAnxiety & Depression (in terms of reduction in scores below 10 for both anxiety & depression)Timepoint: At baseline and at 6 months—

Secondary

MeasureTime frame
1) At least 10% reduction in weight and HbA1c 2) Improvement in co-morbidities and complications (nephropathy) 3) Improvement in biochemical parameters- serum lipids, fasting and post prandial blood glucose levelsTimepoint: AT baseline and at 6 months—

Countries

India

Contacts

Public ContactDr Nidhi Kadam

Freedom From Diabetes Research Foundation

research@freedomfromdiabetes.org9822792772

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026