Gestational Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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German Study Gestational Diabetes (PREG)

Conditions
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Gestational Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with GDM<br> | |
| Women without GDM<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance during 75 g oral glucose tolerance test | Glucose tolerance, insulin sensitivity and insulin secretion during oral glucose tolerance test | Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum | Glucose tolerance during oral glucose tolerance test | Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes) | 
| Body fat distribution | Measurement of body fat distribution by MRS | Once during pregnancy and 1, 2, 5, and 10 years postpartum | 
| Spiroergometry to assess physical fitness | Measurement of VO2max (l/min/kg) as a proxy for physical fitness | 1, 2, 5, and 10 years postpartum | 
| BIA (bioimpedance analysis) | BIA to estimate body fat (%) | Once during pregnancy and 1, 2, 5, and 10 years postpartum | 
| BMI | Measurement of weight (kg) and height (m) and given as kg/m^2 | Once during pregnancy and 1, 2, 5, and 10 years postpartum | 
| Assessment of cognitive abilities in offspring | Cognitive skills represented as an intelligence quotient will be assessed Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) | 6 and 10 years postpartum | 
| Assessment of cognitive, motoric and language development in offspring | Cognitive, motoric and language development of children will be assessed with the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) | 2 years postpartum | 
| BIA in offspring | BIA to estimate body composition in offspring | 2, 6 and 10 years postpartum | 
| Electrocardiogram | 10 minute ECG to assess RR distance for calculation of heart rate variability (R wave distance in ms) | 2, 6 and 10 years postpartum | 
| blood sample | blood sample to assess HbA1C | 6 and 10 years postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, insulin