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NCT Number: NCT04270578

Gestational Diabetes

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glucose tolerance during 75 g oral glucose tolerance test

    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

Secondary outcomes

  1. Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum

    Time frame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)

    Glucose tolerance during oral glucose tolerance test

  2. Body fat distribution

    Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum

    Measurement of body fat distribution by MRS

  3. Spiroergometry to assess physical fitness

    Time frame: 1, 2, 5, and 10 years postpartum

    Measurement of VO2max (l/min/kg) as a proxy for physical fitness

  4. BIA (bioimpedance analysis)

    Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum

    BIA to estimate body fat (%)

  5. BMI

    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

  6. Assessment of cognitive abilities in offspring

    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)

  7. Assessment of cognitive, motoric and language development in offspring

    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)

  8. BIA in offspring

    Time frame: 2, 6 and 10 years postpartum

    BIA to estimate body composition in offspring

  9. Electrocardiogram

    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)

  10. blood sample

    Time frame: 6 and 10 years postpartum

    blood sample to assess HbA1C

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Fritsche, MD

CONTACT

[email protected]

+49 7071 29 ext. 82711

Louise Fritsche, PhD

CONTACT

[email protected]

+49 7071 29 ext. 82711

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • 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

Registry information

Official study title

German Study Gestational Diabetes (PREG)

Acronym: PREG

Important dates

Study start
2012
Primary completion
2027
Study completion
2028
First posted
Feb 17, 2020
Registry last updated
Aug 22, 2022

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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