CTRI/2023/06/053885
Recruiting
未知
Efficacy of lifestyle intervention program on management & remission of type 2 diabetes and its complications â?? DiRemI study - DiRemI
Freedom from diabetes research foundation0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Freedom from diabetes research foundation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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