| CTRI Number |
CTRI/2024/09/073783 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral
Other (Specify) [Lifestyle modification] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study in India: Can a lifestyle program help in improving erectile dysfunction in patients with type 2 diabetes (one year) |
|
Scientific Title of Study
|
Effectiveness of an intensive lifestyle intervention program in improving erectile dysfunction in patients with Type 2 diabetes in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Tripathi |
| Designation |
Director |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drpramod@freedomfromdiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
411004
India
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Freedom from diabetes research foundation First floor, Room no.1, Parth, Ghodke Chowk, Prabhat Road, Pune, MAHARASHTRA, 411004 India (Host Institution) |
|
|
Primary Sponsor
|
| Name |
Freedom From Diabetes Research Foundation |
| Address |
First floor, Room no.1, Parth, Ghodke Chowk, Prabhat Road, Pune, MAHARASHTRA, 411004 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Kadam |
Freedom from Diabetes Clinic |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.7,Parth, Ghodke Chowk Prabhat Road, Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9822792772
research@freedomfromdiabetes.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Freedom from Diabetes Research Foundation- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N521||Erectile dysfunction due to diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle modification |
The duration of the intervention is 1-year. Intervention will consist of Plant-based diet, Physical activity (strength, stamina flexibility exercises including yoga), stress management (Counselling sessions and meditation), routine medical management |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Erectile dysfunction will be measure at baseline, 6 months and at 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
Erectile dysfunction will be measure at baseline, 6 months & at 1 year |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study is a pilot
intervention with a single-arm pre-post design that aims to assess the prevalence
of erectile dysfunction (ED) in patients with T2DM enrolled in a diabetes
remission program and to determine the effect of the program in improving ED
outcomes. Specific Objectives are: 1) To estimate the prevalence of ED among
patients with T2D. 2) To assess the effect of the intervention program on
improvement in ED in patients with T2D. 3) To explore the association between
the ED in patients with diabetes and other health comorbidities as well as
mental health. The intervention includes diet, exercise, medical management of
diabetes. The duration of the intervention will be 6 months. Data will be collected at
two-point times, at the baseline and end-line at the end of 6 months after the delivery
of the intervention. Compliance data will be collected from patients based on
their biochemical parameters. |