Gestational DiabetesPREGNCT04270578
Gestational Diabetes
An observational study of Gestational Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2012to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women in gestational week 24+0 till 31+6 and women postpartum who had a documented occurence of GDM in previous pregnancy.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Andreas Fritsche, MD, +49 7071 29 ext. 82711, andreas.fritsche@med.uni-tuebingen.de
Louise Fritsche, PhD, +49 7071 29 ext. 82711, louise.fritsche@med.uni-tuebingen.de
About this study
Official title: German Study Gestational Diabetes (PREG)
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
- Gestational Diabetes
- Keywords
- gestational diabetes, insulin
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with GDM | Not described | |
| Women without GDM | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance during 75 g oral glucose tolerance test
Glucose tolerance, insulin sensitivity and insulin secretion during oral glucose tolerance test
Measured: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
Secondary outcomes (10)
Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum
Glucose tolerance during oral glucose tolerance test
Measured: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
Body fat distribution
Measurement of body fat distribution by MRS
Measured: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Spiroergometry to assess physical fitness
Measurement of VO2max (l/min/kg) as a proxy for physical fitness
Measured: 1, 2, 5, and 10 years postpartum
BIA (bioimpedance analysis)
BIA to estimate body fat (%)
Measured: Once during pregnancy and 1, 2, 5, and 10 years postpartum
BMI
Measurement of weight (kg) and height (m) and given as kg/m^2
Measured: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Assessment of cognitive abilities in offspring
Cognitive skills represented as an intelligence quotient will be assessed Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V)
Measured: 6 and 10 years postpartum
Assessment of cognitive, motoric and language development in offspring
Cognitive, motoric and language development of children will be assessed with the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)
Measured: 2 years postpartum
BIA in offspring
BIA to estimate body composition in offspring
Measured: 2, 6 and 10 years postpartum
Electrocardiogram
10 minute ECG to assess RR distance for calculation of heart rate variability (R wave distance in ms)
Measured: 2, 6 and 10 years postpartum
blood sample
blood sample to assess HbA1C
Measured: 6 and 10 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start23 May 2012
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf, Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden, Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München, Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel, Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen
- Responsible party
- Sponsor
- Investigators
- Andreas Fritsche, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270578
- Sponsor's protocol ID
- 218/2012BO2
- Acronym
- PREG
- Status last verified
- Aug 2022
- First submitted
- 15 Nov 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer I, Schleger F, Hartkopf J, Veit R, Breuer M, Schneider N, Pauluschke-Frohlich J, Peter A, Preissl H, Fritsche A, Fritsche L. Pre-pregnancy BMI but not mild stress directly influences Interleukin-6 levels and insulin sensitivity during late pregnancy. Front Biosci (Landmark Ed). 2022 Feb 12;27(2):56. doi: 10.31083/j.fbl2702056.
PubMed 35226999Fritsche L, Heni M, Eckstein SS, Hummel J, Schurmann A, Haring HU, Preissl H, Birkenfeld AL, Peter A, Fritsche A, Wagner R. Incretin Hypersecretion in Gestational Diabetes Mellitus. J Clin Endocrinol Metab. 2022 May 17;107(6):e2425-e2430. doi: 10.1210/clinem/dgac095.
PubMed 35180296Fritsche 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.
PubMed 35168986
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Study Gestational Diabetes (PREG)
- ClinicalTrials.gov ID
- NCT04270578
- Acronym / sponsor ID
- PREG / 218/2012BO2
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, insulin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf, Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden, Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München, Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel, Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen
- Study start
- 23 May 2012 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with GDM | – | – |
| Women without GDM | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women in gestational week 24+0 till 31+6 and women postpartum who had a documented occurence of GDM in previous pregnancy.
Key inclusion criteria (4 listed)
- Signed and dated informed consent
- Baseline visit (pregnancy): gestational week 24+0 till 31+6
- Postpartum visits: documented occurence of GDM in previous pregnancy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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)
Body fat distribution
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Spiroergometry to assess physical fitness
Time frame: 1, 2, 5, and 10 years postpartum
BIA (bioimpedance analysis)
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
BMI
Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
Assessment of cognitive abilities in offspring
Time frame: 6 and 10 years postpartum
Assessment of cognitive, motoric and language development in offspring
Time frame: 2 years postpartum
BIA in offspring
Time frame: 2, 6 and 10 years postpartum
Electrocardiogram
Time frame: 2, 6 and 10 years postpartum
blood sample
Time frame: 6 and 10 years postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Derived from this study: PubMed 35226999Bauer I, Schleger F, Hartkopf J, Veit R, Breuer M, Schneider N, Pauluschke-Frohlich J, Peter A, Preissl H, Fritsche A, Fritsche L. Pre-pregnancy BMI but not mild stress directly influences Interleukin-6 levels and insulin sensitivity during late pregnancy. Front Biosci (Landmark Ed). 2022 Feb 12;27(2):56. doi: 10.31083/j.fbl2702056.
- Derived from this study: PubMed 35180296Fritsche L, Heni M, Eckstein SS, Hummel J, Schurmann A, Haring HU, Preissl H, Birkenfeld AL, Peter A, Fritsche A, Wagner R. Incretin Hypersecretion in Gestational Diabetes Mellitus. J Clin Endocrinol Metab. 2022 May 17;107(6):e2425-e2430. doi: 10.1210/clinem/dgac095.
- Derived from this study: PubMed 35168986Fritsche 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Fritsche, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Fritsche, MD (+49 7071 29 ext. 82711, andreas.fritsche@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270578, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.