Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT04270578

Gestational Diabetes

Led by University Hospital Tuebingen · Updated on 2022-08-22

800

Participants Needed

1

Research Sites

831 weeks

Total Duration

On this page

Sponsors

U

University Hospital Tuebingen

Lead Sponsor

D

Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gestational Diabetes

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent
  • Enrollment possible during pregnancy between gestational week 24+0 and 31+6
  • Enrollment possible postpartum if gestational diabetes was documented in previous pregnancy
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Diagnosed with type 1 or type 2 diabetes mellitus
  • Glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2
  • C-reactive protein (CRP) greater than 1 mg/dl
  • Transaminase levels more than twice the upper limit of normal
  • Preexisting heart conditions
  • Weight loss greater than 10% within 6 months before joining
  • Psychiatric disorders
  • Chronic alcohol or substance abuse
  • Use of drugs that increase or decrease blood sugar such as steroids, antidiabetics, or insulin
  • For postpartum visits only: currently pregnant or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Tuebingen

Tübingen, Germany, 72076

Actively Recruiting

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Research Team

A

Andreas Fritsche, MD

CONTACT

L

Louise Fritsche, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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