| CTRI Number |
CTRI/2025/02/079910 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diet consultation] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Dietary intake, glycemic profile and pregnancy outcome of women with PGDM and GDM |
|
Scientific Title of Study
|
Impact of individualized diet consultation on dietary intake, glycemic profile and pregnancy outcome of women with PGDM and GDM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilam Namdeo Ghadge |
| Designation |
Research Scholar |
| Affiliation |
SNDT Womens University Juhu Mumbai |
| Address |
Food Science and Nutrition Department First Floor SNDT Womens University Juhu Tara Rd Daulat Nagar Santacruz west Mumbai Maharashtra 400049
Mumbai (Suburban)
MAHARASHTRA
400049
India |
| Phone |
9833678447 |
| Fax |
|
| Email |
nilamghadge94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Raje |
| Designation |
Research Guide |
| Affiliation |
SNDT Womens University Juhu Mumbai |
| Address |
Food Science and Nutrition Department First Floor SNDT Womens University Juhu Tara Rd Daulat Nagar Santacruz west Mumbai Maharashtra 400049
Mumbai (Suburban)
MAHARASHTRA
400049
India |
| Phone |
9920385557 |
| Fax |
|
| Email |
rajeleena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Raje |
| Designation |
Research Guide |
| Affiliation |
SNDT Womens University Juhu Mumbai |
| Address |
Food Science and Nutrition Department First Floor SNDT Womens University Juhu Tara Rd Daulat Nagar Santacruz west Mumbai Maharashtra 400049
Mumbai (Suburban)
MAHARASHTRA
400049
India |
| Phone |
9920385557 |
| Fax |
|
| Email |
rajeleena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Knowledge Resource Centre Juhu Branch SNDT Womens University Sir Vithaldas Vidyavihar Juhu Tara Road Santacruz West Mumbai 400049 Country India |
|
|
Primary Sponsor
|
| Name |
Nilam Namdeo Ghadge |
| Address |
SNDT Womens University Juhu Tara Rd Daulat Nagar Santacruz west Mumbai Maharashtra 400049 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Tejal Lathia |
THBC The Hormone And Bone Centre |
Diet Department Room no 2 5 Sai Pooja CHS Plot No 52 Sector 14 Vashi 400703
Thane
MAHARASHTRA |
9820246708
drtejallathiaendocrinologist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva mandal Education Societys Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diet consultation |
Individualized diet consultation of women with pre gestational diabetes mellitus and gestational diabetes mellitus |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
pregnant women from 1st day of diagnosis of high blood sugars to 16th to 18th week of gestation will be selected |
|
| ExclusionCriteria |
| Details |
Pregnant women beyond 18th week of gestation T1DM T2DM with major comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recording of dietary history height weight and glycemic profile will be done for all the three groups |
Baseline data collection - 16th to 18th week of gestation
First follow up data collection - 26th to 28th week of gestation
Second follow up data collection - 34th to 36th week of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mothers with abnormal glycemic profiles may not have normal weight gain patterns & pregnancy outcomes in terms of maternal & fetal parameters |
37th week or beyond 37th week of gestation
After the delivery of women at any week of gestation |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
31/03/2025 |
| 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="2"
Months="2"
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
|
With the rise of gestational diabetes mellitus in the present population it is worthwhile to see the effect of GDM on the pregnancy outcome of pregnant women with hyperglycemia and those with normal glycemic profile. This study involves offering individualized dietary counseling and comparing the pregnancy performance of both the groups |