| CTRI Number |
CTRI/2020/06/025807 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Investigation and management of diabetes during pregnancy |
|
Scientific Title of Study
|
Association of biomarkers of insulin receptor substrate pathway with cardiometabolic risks in experimentally-induced gestational diabetes among Wistar rats and effect of yoga on cardiometabolic risks and fetomaternal outcomes in pregnant women with gestational diabetes mellitus: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G K Pal |
| Designation |
Professor (Senior scale) |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
1st Floor
JIPMER Academic Center
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605 006
India |
| Phone |
9344291160 |
| Fax |
|
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G K Pal |
| Designation |
Professor (Senior scale) |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
1st Floor
JIPMER Academic Center
JIPMER
Puducherry
PONDICHERRY
605 006
India |
| Phone |
9344291160 |
| Fax |
|
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G K Pal |
| Designation |
Professor (Senior scale) |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
1st Floor
JIPMER Academic Center
JIPMER
Puducherry
PONDICHERRY
605 006
India |
| Phone |
9344291160 |
| Fax |
|
| Email |
drgkpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry, 605006. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post graduate Medical Education and Research JIPMER |
| Address |
Dhanvantari Nagar
Puducherry 605006 |
| 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 |
| Dr G K Pal |
JIPMER |
Dhanvantari Nagar
Puducherry
605006
Pondicherry
PONDICHERRY |
9344291160
drgkpal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human), JIPMER, Puducherry |
Approved |
| Institute Ethics Committee (Human), JIPMER, Puducherry |
Approved |
| Institute Ethics Committee (Human), JIPMER, Puducherry |
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 |
| Comparator Agent |
No intervention |
GDM without yoga |
| Intervention |
Yoga |
Yoga module for cardiovascular risks
Total duration of yoga sessions- 12 weeks
Supervised session will be conducted once a month when they come for regular antenatal checkup, rest of the days they are advised to practice at home two times a day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed GDM cases
The upper limit of gestational age of GDM cases is 28th completed week of gestation
Women with GDM receiving insulin and/or oral anti-diabetic drugs (cases and controls)
Women with GDM willing to practice yoga (only for cases)
|
|
| ExclusionCriteria |
| Details |
Severe anemia (cases and controls)
Polyhydramnios (cases and controls)
Multiple pregnancy (cases and controls)
Pregnancy induced hypertension (PIH) (cases and controls)
Cardiac problems (cases and controls)
GDM women with the history of PCOS on metformin treatment
BMI > 35 Kg/m2 (cases and controls)
Patients undergoing any kind of yoga therapy or structured exercise (cases and controls)
Patients who are not fit for practicing yoga which includes musculoskeletal problems (Cases)
Patients not willing to deliver in JIPMER (cases and controls)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of supplementing yoga on cardiometabolic risks among pregnant women with Gestational Diabetes Mellitus.
To assess the effect of supplementing yoga on fetomaternal outcomes among pregnant women with Gestational Diabetes Mellitus
|
2 time points.
Initially as soon as the subjects are recruited and 2nd time assessment will be done at 36th weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the association of cardiometabolic risks with fetomaternal outcomes among pregnant women with GDM |
24-36 weeks |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
15/06/2020 |
| 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="2"
Months="6"
Days="2" |
|
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
|
This study is an interventional, comparative study
assessing the effect of yoga practice on cardiovascular risks in 176 GDM women. The study will be conducted in two
years in JIPMER Hospital, Puducherry, India. Anthropometric
measurements, HRV, BRS, body composition will be recorded and blood will be
collected to assess metabolic parameters. Study group participants will undergo
yoga therapy till 36 weeks of gestation/delivery. Control group participants
will not receive intervention. Above mentioned parameters will be assessed at
the end of 36 weeks of gestation for both the groups. The participants will be
followed till 48 hours postpartum for recording fetomaternal outcomes. |