Effect of Freedom from diabetes protocol on weight loss and HbA1c improvement in patient with Type 2 diabetes in India

Not Applicable

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

• Registration Number: CTRI/2023/06/053885
• Lead Sponsor: Freedom from diabetes research foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Written informed consent.

2. Men and women aged 30-70 years.

3. T2D duration <15 years.

4. Confirmed diagnosis of type 2 Diabetes- All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic anti-diabetic medications or HbA1c >= 48 mmol/mol (6.5%) with or without medication.

5. Body mass index (BMI) >25 kg/m2 and <35 kg/m2.

6. Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation.

7. Well-oriented in time, space & as a person.

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. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation).

3. Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation).

4. eGFR <45mL/min/1.73m2 and/or albuminuria >=300mg).

5. Known history of retinopathy or neuropathy.

6. Previous history of heart attack, cardiac arrhythmia, bypass or stent placement surgery, ischemic heart disease, Angina (Class III & IV), myocardial infarction within the previous 6 months, reported heart failure (reduced LV ejection fraction <=40%), ECG not within normal limits, reported positive stress test which is moderate to severe.

7. A known diagnosis of cancer.

8. Pregnant or lactating women.

9. Patients who have required hospitalization for any diabetes-related complications in the last 6 months or for depression or are on antipsychotic drugs.

10. Physical ailments (like spine issues, arthritis, etc.) that limit the implementation of the exercise protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified