Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
Study Details
Study Description
Brief Summary
Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.
In this study, women with previous GDM and a control group matched on age, time of birth and BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post partum examination (GDM only) will be used to identify risk factors for later development of DM. Further, life-style factors and mental health according to diabetes status will be studied.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Background
It is well established that women with previous GDM are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). Furthermore, GDM is a heterogeneous condition covering both women with a strong genetic disposition to type 2 DM, women in the early stages of autoimmune DM and rare cases of monogenetic DM. These latent disorders of glucose metabolism are damasked by the metabolic stress of pregnancy.
Aims
-
To study predictors of DM and pre-DM after GDM: a) At the time of pregnancy: age, blood pressure, pre-pregnancy Body Mass Index (BMI), b) 3 months post partum: indices of insulin sensitivity and beta-cell function, lipid profile, GAD-autoantibodies, HbA1c
-
To study lifestyle factors 7-8 years after GDM pregnancy in relation to current diabetes status
Materials and methods
During 2011-2017 women with previous GDM and a control group are invited to a long-term follow-up. Data collection is performed 7-8 years after pregnancy. GDM subjects (n150), controls (n50):
-
Anthropometrics: weight, height, waist circumference, blood pressure and length
-
Analyses: p-glucose, s-insulin at 0, 30 and 120 minutes during a 2-h 75 g OGTT. Fasting: total cholesterol, HDL, LDL triglycerides, GAD- autoantibodies, Hba1C, Urine albumin/creatinine ratio.
-
Questionnaires: Information on lifestyle and health status
Data available around pregnancy
Pregnancy data from hospital journals (GDM subjects and controls):
Examinations 3 months post-partum (GDM subjects only):
Clinical examination, 2-h 75 g OGTT with measurements of p-glucose and s- insulin at 0, 30 and 120 minutes, fasting total cholesterol, HDL, LDL and triglycerides, HbA1c and GAD- autoantibodies.
Perspectives
Our current population is unique as clinical, metabolic and autoimmune markers were determined prospectively a few months after GDM pregnancy and at follow-up. Hopefully, the results will enable us to target preventive actions in women with previous GDM and improve our understanding of pathophysiologic mechanisms in pre-diabetic conditions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| previous GDM Women with previous GDM |
|
| no previous GDM Women without previous GDM matched on age, pregestational body mass index end time of pregnancy. |
Outcome Measures
Primary Outcome Measures
- Type 2 diabetes [7 to 8 years after giving birth]
Secondary Outcome Measures
- Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test [7 to 8 years after giving birth]
- Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test [7 to 8 years after giving birth]
- Body mass index (kg/m2) [7 to 8 years after giving birth]
- Blood pressure (mmHg) [7 to 8 years after giving birth]
- Questionnaires, quality of life (SF12), physical and mental summary scores [7 to 8 years after giving birth]
- Questionnaires, mental health (WHO-5), WHO-Five well being index [7 to 8 years after giving birth]
- Questionnaires, physical activity (PAS 2), physical activity score [7 to 8 years after giving birth]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Previous GDM with information from post partum OGTT
-
Danish speaking
Exclusion Criteria:
-
Bariatric surgery
-
Poorly controlled psychiatric disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern Denmark | Odense | Denmark | 5000 |
Sponsors and Collaborators
- University of Southern Denmark
Investigators
- Principal Investigator: Dorte M Jensen, University of Southern Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- University of Southern Denmark