Gestational Diabetes

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT04270578
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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)
BIA in offspring	2, 6 and 10 years postpartum	BIA to estimate body composition in offspring
blood sample	6 and 10 years postpartum	blood sample to assess HbA1C
Spiroergometry to assess physical fitness	1, 2, 5, and 10 years postpartum	Measurement of VO2max (l/min/kg) as a proxy for physical fitness
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)
Body fat distribution	Once during pregnancy and 1, 2, 5, and 10 years postpartum	Measurement of body fat distribution by MRS
BIA (bioimpedance analysis)	Once during pregnancy and 1, 2, 5, and 10 years postpartum	BIA to estimate body fat (%)
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)

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany