PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes

PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)

Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.

Study Overview

• Status: Recruiting
• Conditions: Offspring Exposed to GDM and Control
• Intervention / Treatment: Other: intrauterine exposure to elevated glucose levels

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Louise Fritsche, Dr. rer. nat.; Phone Number: 07071-2980687; Email: louise.fritsche@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • University Hospital Tübingen
    • Contact: Louise Fritsche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants are children from mothers that are enrolled in the PREG study.

Description

Inclusion Criteria:

• signed informed consent provided by child and parent
• documented oral glucose tolerance test of the mother during pregnancy
• adequate management of gestational diabetes until birth

Exclusion Criteria:

• severe malformation that makes an examination impossible
• existent of coagulation disorder with increased risk of bleeding after blood sampling

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GDM	Other: intrauterine exposure to elevated glucose levels; intrauterine exposure to elevated glucose levels
non-GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body height	Body height is measured with a tape measure in centimeter (cm)	Change in body height from birth to age 6, 10, 14 and 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight is measured with a scale in kilogram (kg)	Change in body weight from birth to age 6, 10, 14 and 17
Body fat	Body fat content is measured with bioimpedance anaylsis in percent (%)	Change of body fat from age 6 to age 10, 14 and 17
Blood pressure	Blood pressure is measured with a blood pressure monitor as systolic and diastolic pressure in millimeter mercury column (mm Hg)	Change of blood pressure from age 6 to age 10, 14 and 17
Pubertal development scale	Pubertal development scale is assessed according to Tanner stages	Change of pubertal development scale from age 6 to age 10, 14 and 17
Blood glucose	Blood glucose is measured in blood sample in miligram per deciliter (mg/dl)	Change of blood glucose from age 6 to age 10, 14 and 17
HbA1C	HbA1C is measured in blood sample in percent (%)	Change of HbA1C from age 6 to age 10, 14 and 17
Cardiometabolic risk markers	Cholesterol, Low-density Lipoprotein, High-density Lipoprotein, Triglycerides, Lipoprotein(a) are measured in blood sample in mg/dl	Change of cardiometabolic risk markers from age 6 to 10, 14 and 17
Continuous glucose monitoring	24h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring	Change of blood glucose from age 6 to age 10, 14 and 17
Activity level	Activity level is assessed with the MOMO activity questionnaire	Change of activity level from age 6 to 10, 14 and 17
Magnetic resonance imaging	Distribution of whole body fat and visceral and subcutaneous fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3T Whole Body Imager	Change of magnetic resonance images from age 6 to 10, 14 and 17

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Andreas Fritsche, University Hospital Tübingen

Publications and helpful links

General Publications

• Fritsche L, Hummel J, Wagner R, Loffler D, Hartkopf J, Machann J, Hilberath J, Kantartzis K, Jakubowski P, Pauluschke-Frohlich J, Brucker S, Horber S, Haring HU, Roden M, Schurmann A, Solimena M, de Angelis MH, Peter A, Birkenfeld AL, Preissl H, Fritsche A, Heni M. The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design. BMJ Open. 2022 Feb 15;12(2):e058268. doi: 10.1136/bmjopen-2021-058268.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): January 15, 2036
• Study Completion (Anticipated): September 15, 2036

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 617/2020BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No