Gestational Diabetes
Conditions
Keywords
gestational diabetes, insulin
Brief summary
Due to a changed lifestyle with less physical activity, unfavorable diets rich in fat and calories and obesity, the prevalence of diabetes mellitus is increasing worldwide. The diabetes epidemic is associated with significant personal and socio-economic consequences. Despite attempts to prevent the complications of diabetes, this disease is still the leading cause of blindness, chronic renal insufficiency and non-traumatic amputation. It is important to detect early on an increase in blood sugar and treat it accordingly to reduce costs and to minimize the personal suffering of those affected. As the number of patients with type 2 diabetes mellitus continues to rise, the number of young women with gestational diabetes mellitus (GDM) also increases. This is a disorder og glucose metabolism, which occurs for the first time in pregnancy. The causes for this are manifold. Among other causes, the increasing age of the mothers and weight gain during pregnancy are risk factors for gestational diabetes. Although it has been recommended that women with gestational diabetes should be re-examined after the birth of their child, many women have not. The study is a follow-up study to clarify whether insulin secretion disorder in women with and after GDM is a risk factor for the occurrence of type 2 diabetes mellitus.
Interventions
None listed
Sponsors
Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf
Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden
Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München
Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel
Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen
University Hospital Tuebingen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Signed and dated informed consent Enrollment is possible during AND after gestation: * Baseline visit (pregnancy): gestational week 24+0 till 31+6 * Postpartum visits: documented occurence of GDM in previous pregnancy
Exclusion criteria
* Age \< 18years * Diabetes Mellitus Type 1 or Type 2 * GFR \< 60 ml/min/1,73 m2 * CRP \> 1 mg/dl * Increased levels of transaminases 2 fold above ULN * Preexisting cardiac conditions * Weight loss \> 10% within 6 months prior to inclusion * Psychiatric disorders * Chronic alcohol or substance abuse * Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin * only postpartum visits: pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose tolerance during 75 g oral glucose tolerance test | Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes) | Glucose tolerance, insulin sensitivity and insulin secretion during oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat distribution | Once during pregnancy and 1, 2, 5, and 10 years postpartum | Measurement of body fat distribution by MRS |
| Spiroergometry to assess physical fitness | 1, 2, 5, and 10 years postpartum | Measurement of VO2max (l/min/kg) as a proxy for physical fitness |
| BIA (bioimpedance analysis) | Once during pregnancy and 1, 2, 5, and 10 years postpartum | BIA to estimate body fat (%) |
| BMI | Once during pregnancy and 1, 2, 5, and 10 years postpartum | Measurement of weight (kg) and height (m) and given as kg/m\^2 |
| Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum | Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes) | Glucose tolerance during oral glucose tolerance test |
| Assessment of cognitive, motoric and language development in offspring | 2 years postpartum | Cognitive, motoric and language development of children will be assessed with the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) |
| BIA in offspring | 2, 6 and 10 years postpartum | BIA to estimate body composition in offspring |
| Electrocardiogram | 2, 6 and 10 years postpartum | 10 minute ECG to assess RR distance for calculation of heart rate variability (R wave distance in ms) |
| blood sample | 6 and 10 years postpartum | blood sample to assess HbA1C |
| Assessment of cognitive abilities in offspring | 6 and 10 years postpartum | Cognitive skills represented as an intelligence quotient will be assessed Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) |
Countries
Germany
Contacts
Primary ContactAndreas Fritsche, MD
Backup ContactLouise Fritsche, PhD
Outcome results
None listed