| CTRI Number |
CTRI/2020/08/027439 [Registered on: 28/08/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
body fat composition analysis in Indians with recently diagnosed diabetes. |
|
Scientific Title of Study
|
Body composition in Asian Indians with recently diagnosed Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Goel |
| Designation |
Junior Resident, Internal Medicine |
| Affiliation |
PGIMER |
| Address |
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8851741753 |
| Fax |
|
| Email |
dr.rohangoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu Rastogi |
| Designation |
Assistant Professor, Department of Endocrinology, PGIMER, Chandigarh |
| Affiliation |
PGIMER |
| Address |
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09781001046 |
| Fax |
|
| Email |
ashuendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Goel |
| Designation |
Junior Resident, Internal Medicine |
| Affiliation |
PGIMER |
| Address |
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
room no 16, block A1, Nehru extension block, Department of endocrinology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8851741753 |
| Fax |
|
| Email |
dr.rohangoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thesis grant, Department of Endocrinology, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Madhya Marg, Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of endocrinology |
PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rohan Goel |
PGIMER, Chandigarh |
room no 16, block A1, Nehru extension block, Department of endocrinology
Chandigarh
CHANDIGARH |
8851741753
dr.rohangoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to give informed
consent to participate in the study.
2. Patients diagnosed with Type 2 Diabetes
Mellitus within a period of 24 weeks, as per
ADA Diagnostic Criteria of Type 2 Diabetes
Mellitus |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to give consent
to participate in the study or to undergo
DEXA, Bioelectrical Impedance, or blood
Investigatons.
2. Patients with duration of Type 2 Diabetes
Mellitus more than 24 weeks.
3. Patients taking drug therapy like Insulin,
SGLT 2 Inhibitors and Sulphonylureas. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visceral fat mass(g), volume (cm3), area(cm2) via DEXA scan |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visceral fat rating via Bioelectrical Impedance, values of Biomarkers (Adiponectin, Chemerin, hsCRP), Anthropometry (Waist Circumference, Hip Circumference, Waist to Hip ratio, BMI) |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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)
|
28/08/2020 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are numerous risk factors that predispose one to developing T2 DM, like family history of Diabetes, obesity, sedentary life style etc. Amongst all of them, our study tends to elaborate on the correlation between obesity and T2 DM. Till now, Anthropometric measures like WC, WHR and BMI are being used as surrogate measures of obesity. But it has been found that Asian Indians are predisposed to develop Diabetes even at a lower BMI. With this scenario, it seems worthwhile to delve into knowing the total body composition and body fat distribution, both quantitatively and qualitatively, so as to predict the predisposition to Type 2 DM, using methods like Bioelectrical Impedance and Whole Body DEXA which provide more accurate measurements of the same. Along with this, we tend to measure the levels of various inflammatory biomarkers like adiponectin, chemerin and hsCRP, as Diabetes is considered as the state of low grade inflammation. Thus, we tend to study the body composition (structural and biochemical) in Asian Indians with recently diagnosed type 2 Diabetes Mellitus, with an intent to corroborate our hypothesis that the thin lean Asian Indian phenotype is a myth and that the Asian Indians developing T2 DM are also obese fat, similar to the Caucasian phenotype. |