Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Sponsors
Freedom from diabetes research foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Men and women aged 30-70 years. 3. T2D duration 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 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
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 =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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: HbA1c & weight will be measured at baseline, at 6 months & at the end of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Mental Health (in terms of reduction in scores below 10 for both anxiety & depression), b) Improvement in Co-morbidities & diabetes-related complications (nephropathy), c) Biochemical parameters e.g., Improvement in-Serum Lipids, Fasting and post prandial plasma glucose, creatinine/eGFR.Timepoint: For Mental health- At baseline & at 6 months Co-morbidities & complications- At baseline, 6 months & at 12 months For biochemical parameters- AT baseline, at 6 months and at end of 12 months | — |
Countries
India
Contacts
Public ContactDr Nidhi Kadam
Freedom From Diabetes Research Foundation
Outcome results
None listed