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临床试验/CTRI/2023/06/053885
CTRI/2023/06/053885招募中Unknown

Efficacy of lifestyle intervention program on management & remission of type 2 diabetes and its complications â?? DiRemI study - DiRemI

Freedom from diabetes research foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Freedom from diabetes research foundation

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