NCT04270578: PREG

Gestational Diabetes

Recruiting now Last updated 22 August 2022

What this trial tests

trial in Gestational Diabetes in 800 participants. Currently enrolling.

Timeline

23 May 2012

Primary endpoint
1 May 2027

1 May 2028

Quick facts

Lead sponsor	University Hospital Tuebingen
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	800
Start date	23 May 2012
Primary completion	1 May 2027
Estimated completion	1 May 2028
Sites	1 location across Germany

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

University Hospital Tuebingen

Who can join

18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reproducibility and discrimination of different indices of insulin sensitivity and insulin secretion.
   Hudak S, Huber P, Lamprinou A, Fritsche L, et al · · 2021 · cited 28× · PMID 34679116 · DOI 10.1371/journal.pone.0258476
2. Incretin Hypersecretion in Gestational Diabetes Mellitus.
   Fritsche L, Heni M, Eckstein SS, Hummel J, et al · · 2022 · cited 19× · PMID 35180296 · DOI 10.1210/clinem/dgac095
3. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
4. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
5. 58^th EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
   · 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
6. The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design.
   Fritsche L, Hummel J, Wagner R, Löffler D, et al · · 2022 · cited 5× · PMID 35168986 · DOI 10.1136/bmjopen-2021-058268
7. Effect of Breastfeeding Duration on Coagulation in Women With and Without History of Gestational Diabetes Mellitus.
   Fritsche L, Löffler D, Kantartzis K, Flehmig G, et al · · 2024 · cited 3× · PMID 38487818 · DOI 10.1210/clinem/dgae172
8. Maternal Weight Gain during Pregnancy and the Developing Autonomic Nervous System-Possible Impact of GDM.
   Fritsche L, Hartkopf J, Hummel J, Löffler DS, et al · · 2022 · cited 2× · PMID 36558379 · DOI 10.3390/nu14245220