Health Condition 1: N521- Erectile dysfunction due to diseases classified elsewhere
Conditions
Sponsors
Freedom From Diabetes Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age - 30 to 60 years at the time of enrollment 2. Male participants with confirmed 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 3. Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation 4. Participants who are well-oriented in time, and space & as a person 5. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes (due to autoimmune β-cell destruction) usually leads to absolute insulin deficiency, including latent autoimmune diabetes in adulthood. 2) Specific types of diabetes due to other causes, such as 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 glucocorticoid use, HIV/AIDS treatment, or organ transplantation). 3) Patients who required hospitalization for any diabetes-related complications or for depression in the last 6 months or are on antipsychotic drugs. 4) Known cancer 5) Patients with conditions that could significantly affect penile erection that include spinal cord injuries and known or suspected chronic debilitating illnesses such as chronic heart failure, chronic renal failure, chronic liver, disease, chronic obstructive pulmonary diseases, tuberculosis, and malignancy, regardless of diabetes. 6) Patients on drug treatment of ED or drug-induced ED for example beta blockers, antihypertensive medication, antidepressants and other medicines for mental health conditions, antihistamine medicines, or parkinson disease medicines) 7) Patients with self reported genital anatomic deformities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate the impact of the FFD protocol on improvement in Erectile dysfunction score from severe (5-7) to mild (17-21) in patients with T2D.Timepoint: Erectile dysfunction will be measure at baseline, 6 months and at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Estimate the prevalence of ED among patients with T2D. 2. Explore the association between erectile dysfunction (ED) & health comorbidities, as well as mental health. Timepoint: Erectile dysfunction will be measure at baseline, 6 months & at 1 year | — |
Countries
India
Contacts
Public ContactDr Nidhi Kadam
Freedom From Diabetes Research Foundation
Outcome results
None listed