University Hospital Tuebingen
Tübingen, 72076, Germany
Location status: Recruiting
Location contact
Andreas Fritsche, MD
CONTACT
+49 7071 29 ext. 82711
Louise Fritsche, PhD
CONTACT
+49 7071 29 ext. 82711
NCT Number: NCT04270578
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Tübingen, 72076, Germany
Location status: Recruiting
Andreas Fritsche, MD
CONTACT
+49 7071 29 ext. 82711
Louise Fritsche, PhD
CONTACT
+49 7071 29 ext. 82711
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Enrollment is possible during AND after gestation:
Exclusion criteria
Time frame: 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
Time frame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
Glucose tolerance during oral glucose tolerance test
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Measurement of body fat distribution by MRS
Time frame: 1, 2, 5, and 10 years postpartum
Measurement of VO2max (l/min/kg) as a proxy for physical fitness
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
BIA to estimate body fat (%)
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Measurement of weight (kg) and height (m) and given as kg/m^2
Time frame: 6 and 10 years postpartum
Cognitive skills represented as an intelligence quotient will be assessed Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V)
Time frame: 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)
Time frame: 2, 6 and 10 years postpartum
BIA to estimate body composition in offspring
Time frame: 2, 6 and 10 years postpartum
10 minute ECG to assess RR distance for calculation of heart rate variability (R wave distance in ms)
Time frame: 6 and 10 years postpartum
blood sample to assess HbA1C
Contact information is provided by the study sponsor or research team.
Andreas Fritsche, MD
CONTACT
+49 7071 29 ext. 82711
Louise Fritsche, PhD
CONTACT
+49 7071 29 ext. 82711
University Hospital Tuebingen
Other
German Study Gestational Diabetes (PREG)
Acronym: PREG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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