Home » Trials » SLCTR/2015/021
Impact of life style adjustments on glycaemic status and surrogate markers of diabetes mellitus in postpartum women with diagnosed Gestational Diabetes Mellitus (GDM)
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SLCTR Registration Number
SLCTR/2015/021
Date of Registration
The date of last modification
Oct 04, 2024
Trial Status
Scientific Title of Trial
Impact of life style adjustments on glycaemic status and surrogate markers of diabetes mellitus in postpartum women with diagnosed Gestational Diabetes Mellitus (GDM)
Public Title of Trial
Life style adjustment in Gestational Diabetes Mellitus (GDM)
Disease or Health Condition(s) Studied
Gestational diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
Study of the impact of lifestyle adjustment in Gestational Diabetes mellitus
Universal Trial Number
U1111-1168-4119
Any other number(s) assigned to the trial and issuing authority
ERC/University of Sri jayewardenapura 52/14
What is the research question being addressed?
What is the association between exercise ad dietary intervention with insulin resistance and inflammatory response in postpartum women with diagnosed GDM?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the Castle Street Hospital for Women and the De Soysa Maternity Hospital.
Participants will be invited to attend a special clinic in the department of Clinical Medicine, Colombo for data collection.
A total of 100 postpartum women who meet the inclusion and exclusion criteria will be recruited soon after delivery (before discharge) from Castle Street Maternity Hospital for Women and De Soysa Maternity Hospital. Each of the 12 clinics will be randomized (cluster randomization) to be allocated either intervention or routine care (control). The participants registered at each clinic, will thus be allocated accordingly to the two arms.
Arm A: Intervention arm (diet and physical activity modifications counseling) 1. Participants will undergo standardized individual counselling sessions by a trained investigator, lasting 30-60 minutes each. Session will address diet and exercise and a customized plan will be given. 2. Participants will be reviewed every 3 months for one year (total of 4 visits, including at the initial session). Diet and exercise plan will be adjusted based on pre-determined criteria in the outcomes. Based on pre-determined criteria, further counselling sessions lasting 30-60 minutes will be offered. 3. Standard management according to clinic protocols will continue.
Arm B: Control arm Participants will receive only standard management according to clinic protocols.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[
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Secondary outcome(s)
|
1.
|
[ Every 3 months for a total of 12 months ] |
Target number/sample size
100 (50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2017-04-01
Date of first enrollment
2016-01-01
Date of study completion
2018-10-06
Recruitment status
Complete: follow up complete
Funding source
University of Sri Jayewardenapura (Grant no. ASP/06/RE/MED/2013/39)
Regulatory approvals
Status
Approved
Date of Approval
2014-11-12
Approval number
52/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
S.M.T.D Sundarapperuma
Lecturer
B.Sc Nursing Degree Programme,
Faculty of Medicine,
University of Ruhuna
Tel: 0912243241
Mob: 0713186524
chamudi2006@yahoo.com
Contact Person for Public Queries
Prof P. Hettiarachchi
Professor
Department of Physiology
Faculty of Medical Sciences
University of Sri Jayewardenapura
Mob: 0718432344
priyadarshikahett@gmail.com
Primary study sponsor/organization
University of Sri Jayewardenapura
Gangodawila, Nugegoda,
Sri Lanka.
Tel: +94 11 2758000, +94 11 2802022, +94 11 2801024,
Fax: +94 11 2801025
http://www.sjp.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
Date of study completion
2018-10-06
Final sample size
70
Date of first publication
2018-08-26
Link to results
Brief summary of results
Results showed that the insulin resistance (median) was significantly lower in the intervention group (0.98) compared to the controls (1.94) at 12 months postpartum. Although anthropometric measurements (weight, waist circumference, WHR, WHtR) and glycemic parameters (FBG, OGTT, HbA1c) were comparable at baseline in both groups, they were significantly lower in the intervention group compared to the control group at 12 months. The impact of the intervention on inflammation was inconclusive.
