Gestational Diabetes

Gestational Diabetes Clinical Trial

— PREG  

Official title:

German Study Gestational Diabetes (PREG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270578
• Other study ID #: 218/2012BO2
• Status: Recruiting
• Start date: May 23, 2012
• Est. completion date: May 1, 2028

Study information

• Verified date: August 2022
• Source: University Hospital Tuebingen
• Contact: Andreas Fritsche, MD
• Phone: +49 7071 29
• Email: andreas.fritsche[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf, Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München, Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden, Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel, Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen

Country where clinical trial is conducted

Germany, 

Outcome

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