| CTRI Number |
CTRI/2017/01/007750 [Registered on: 31/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of lifestyle modification on the incidence of diabetes in persons with prediabetes on one time testing |
|
Scientific Title of Study
|
A prospective analysis of the impact of lifestyle modification on the incidence of Type 2 diabetes in persons with single-time IGT. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IDRFARH008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof A Ramachandran |
| Designation |
President |
| Affiliation |
India Diabetes Research Foundation |
| Address |
President
India Diabetes Research Foundation
Chairman
Dr A Ramachandrans Diabetes Hospitals
No 28 Marshalls Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9841080605 |
| Fax |
|
| Email |
research@ardiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Snehalatha |
| Designation |
Director Research |
| Affiliation |
India Diabetes Research Foundation |
| Address |
India Diabetes Research Foundation
No 28 Marshalls Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9840323058 |
| Fax |
|
| Email |
snehalatha@vsnl.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Snehalatha |
| Designation |
Director Research |
| Affiliation |
India Diabetes Research Foundation |
| Address |
India Diabetes Research Foundation
No 28 Marshalls Road
Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
9840323058 |
| Fax |
|
| Email |
snehalatha@vsnl.com |
|
|
Source of Monetary or Material Support
|
| India Diabetes Research Foundation, No 28 Marshalls Road, Egmore, Chennai 600008 |
|
|
Primary Sponsor
|
| Name |
India Diabetes Research Foundation |
| Address |
No 28 Marshalls Road
Egmore
Chennai 600008
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof A Ramachandran |
Visakha Steel General Hospital |
Sector 6, Ward 4
Ukkunagaram
Visakhapatnam 530032
Visakhapatnam
ANDHRA PRADESH |
9841080605
ramachandran@vsnl.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Employees identified with Impaired Glucose Tolerance on the first Oral Glucose Tolerance Test reverted to normoglycaemia or diagnosed with diabetes on the confirmatory OGTT performed within a week |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
In a diabetes screening programme conducted in 2010, participants identified with impaired glucose tolerance (IGT) on the first oral glucose tolerance test (OGTT) who reverted to normoglycaemia or diagnosed with diabetes on the confirmatory OGTT performed within a week will be followed up after a period of 5 years |
|
| ExclusionCriteria |
| Details |
1 Persons not participated in the diabetes screening programme conducted in 2010
2 Persons identified with normoglycaemia in screening OGTT
3 persons diagnosed with diabetes in screening OGTT
4 Persons identified with persistent IGT (screening and confirmatory OGTT) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Type 2 diabetes |
5 years since diabetes screening conducted in 2010 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Development of cardiovascular risk
Change in healthy lifestyle practices
Improvement in knowledge on diabetes awareness |
5 years since diabetes screening conducted in 2010 |
|
|
Target Sample Size
|
Total Sample Size="709"
Sample Size from India="709"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Ambady Ramachandran, Chamukuttan Snehalatha, et al. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modifi cation in men in India: a prospective, parallel-group, randomised controlled trial Lancet Diabetes Endocrinol 2013; 1: 191–98
Arun Nanditha, Jagannathan Ram, et al. Early improvement predicts reduced risk of incident diabetes and improved cardiovascular risk in prediabetic Asian Indian men participating in a 2-year lifestyle intervention program Diabetes Care. 2014;37:3009-3015
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present proposal is to conduct a prospective survey among the Visakhapatnam steel plant employees who were screened for Impaired Glucose Tolerance (IGT) to recruit in a diabetes primary prevention trial conducted in 2010. Participants were educated and advised on healthy lifestyle principles during the screening programme and printed educational materials on diabetes were distributed. The proposed follow up after 5 years will provide an opportunity to assess the sustained effect of standard care lifestyle education on healthy lifestyle (dietary habits and physical activity). This will help us understand the effect of lifestyle education for the prevention of diabetes and also an estimate of the incidence of diabetes among participants with IGT in the real world situation. The primary outcome measure is incidence of Type 2 diabetes among high risk individuals (IGT) 5 years following advice on healthy lifestyle principles. The secondary outcomes are: - Assessment of the cardio metabolic variables
- Changes in lifestyle (dietary and physical activity practices)
- Improvement in knowledge on diabetes
|