NCT05112588: PEPP

Gestational Diabetes - PrEvention of PostPartum Diabetes Study

Recruiting now NA Last updated 13 June 2024

What this trial tests

NA trial testing Intervention in Gestational Diabetes in 600 participants. Currently enrolling.

Timeline

1 November 2021

Primary endpoint
31 December 2025

31 December 2030

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	600
Start date	1 November 2021
Primary completion	31 December 2025
Estimated completion	31 December 2030
Sites	1 location across Sweden

Drugs / interventions tested

• Intervention

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

Adults 18 to 60, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines.

The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021.

The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.