Gestational Diabetes
Conditions
Interventions
The study will be conducted in 4 hospital sites
• Colombo North Teaching Hospital, Ragama
• Colombo South Teaching Hospital, Kalubowila
• Negombo District General Hospital
• De Soysa Hospital for
Sponsors
Dr. Anushka Patel
Eligibility
Inclusion criteria
Inclusion criteria: Absence of type 2 diabetes mellitus (T2DM) as confirmed by findings of Impaired Glucose Tolerance, Impaired Fasting Glucose, Normal Glucose Tolerance at the at 6±3 months post-partum OGTT (Oral Glucose Tolerance Test)
Exclusion criteria
Exclusion criteria: 1. Place of residence outside the catchment of the treating hospital 2. Lack of access to a mobile telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women with a change of glycaemic category, at or prior to final visit: • Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM • IFG or IGT to T2DM [At baseline and at the final visit. (The median follow up period of the study is 24 months and minimum follow up is 12 months.The end of study visit would be different for each participant depending on when they are randomized) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in Fasting plasma glucose [At baseline and then 6 monthly until the end of the follow-up period.] Percentage reduction in : Area under the curve of OGTT [At baseline and then 6 monthly until the end of the follow-up period.] Percentage reduction in Body weight [At baseline and then 6 monthly until the end of the follow-up period. ] Percentage reduction in Waist circumference [At baseline and then 6 monthly until the end of the follow-up period. ] Percentage reduction in Systolic blood pressure [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Physical activity level using the GPAQ (global physical activity questionnaire [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Diet using 24 hour diet recall [At baseline and then 6 monthly until the end of the follow-up period. ] Improvement of Quality of life using the EQ5D questionnaire [At baseline and then 6 monthly until the end of the follow-up period. ] Affordability: will be measured using a specific health economic model using health care costs and outcomes both within trial and on long term basis. [At baseline and then 6 monthly until the end of the follow-up period. ] | — |
Countries
Bangladesh,India,Sri Lanka
Contacts
Public ContactProf Asita de Silva
Director
Outcome results
None listed