- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617405
Hormonal and Inflammatory Changes During Pregnancy in Women With Glucose Metabolic Disorders. (HI-MET)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective observational study including app. 300 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg, Odense and Aarhus University Hospital.
The study includes 50 healthy normal-weight women, 150 healthy overweight women, 50 women with gestational diabetes and 50 women with type 2 diabetes.
Hormonal profiles and inflammatory markers will be measured at gestational week 8-10, 10-14, 18-22, 24-28 and 34-38. The blood samples will include HbA1c, glukose, insulin, C-peptid, lipid profile, liver enzymes, creatinine, FGF-21, TSH, Cortisol, human chorionic gonadotropin, estradiol, progesterone, prolactin, human placental lactogen, placental growth hormone, IGF-1, IGF-BP's, Leptin, Adiponectin, GLP-1, GIP, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM and CD163. In addition to this, exosomes will be isolated precisely and profiling of the content of exosomes will be performed using in vitro assays. Proteomics and miRNAs sequencing will be employed.
Height, weight, and blood pressure will be measured at every visit and a urine sample will be collected.
Insulin sensitivity will be estimated using the homeostasis model assessment, IS-HOMA, based on fasting insulin and glucose concentrations.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Per G Ovesen, Prof., M.D.
- Email: perovese@rm.dk
Study Contact Backup
- Name: Anna S Koefoed, M.D.
- Phone Number: +45 93 50 80 69
- Email: annask@clin.au.dk
Study Locations
-
-
-
Aalborg, Denmark, 9100
- Recruiting
- Aalborg University Hospital
-
Contact:
- Anne W Sørensen, M.D.
- Phone Number: +45 93 50 80 69
- Email: anns@rn.dk
-
Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
-
Contact:
- Lise Lotte T Andersen, MD
- Phone Number: +45 93 50 80 69
- Email: lise.lotte.andersen@rsyd.dk
-
-
Aarhus N
-
Aarhus, Aarhus N, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Per G Ovesen, Prof., M.D.
- Email: perovese@rm.dk
-
Contact:
- Anna S Koefoed, M.D.
- Phone Number: +45 93 50 80 69
- Email: annask@clin.au.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women at The Department of Gynaecology and Obstetrics at Aarhus University Hospital, Aalborg University Hospital or Odense University Hospital.
- Women have to be in 1 of 4 categories: Healthy with a BMI < 25, healthy with a BMI >= 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes
Exclusion Criteria:
- Age < 18 years
- Not able to read and understand danish
- Previous bariatric surgery
- Treatment with systemic corticosteroids
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type A
Healthy normal-weight pregnant women
|
No interventions
|
Type B
Pregnant women with gestational diabetes diagnosed at early screening (before gestational week 20)
|
No interventions
|
Type C
Pregnant women with type 2 diabetes
|
No interventions
|
Type D
Healthy overweight pregnant women
|
No interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers at four other times during pregnancy.
Time Frame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Serum concentration of IGF-1, IGFBP-3, IGFBP-1, FGF-21, Leptin, Adiponectin, CD163, Human Chorionic Gonadotropin, Progesterone, C-peptide, Cortisol, Prolactin, Sex Hormone Binding Globulin, Estradiol, Free fatty acids, Human Placental Lactogen and Human Placental Growth Hormone. Plasma concentrations of IL-6, IL-10, IL-1alpha, IFN-gamma, TNF-alpha, ICAM1, VCAM, LDL, HDL, Triglyceride, Gamma-Glutamyl Transferase, Thyrotropin, glucose and HbA1c. |
Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity at five times during pregnancy.
Time Frame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Association between the metabolic, hormonal and inflammatory markers listed as Primary Outcome 1 and the Insulin sensitivity.
Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
|
Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma at four other times during pregnancy.
Time Frame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.
|
Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity at five times during pregnancy.
Time Frame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.
Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
|
Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in blood pressure (systolic and diastolic) at four other times during pregnancy.
Time Frame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg).
|
Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Changes from baseline in body weight at four other times during pregnancy.
Time Frame: Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Body weight measured in kilograms.
|
Gestational week 8-10 (baseline), gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Association between the blood pressure (systolic and diastolic) Versus Insulin sensitivity at five times during pregnancy.
Time Frame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg).
Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
|
Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Association between the body weight Versus Insulin sensitivity at five times during pregnancy.
Time Frame: Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Body weight measured in kilograms.
Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting insulin and glucose concentrations.
|
Gestational week 8-10, gestational week 10-14, gestational week 18-22, gestational week 24-28 and gestational week 34-38
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna S Koefoed, M.D., Aarhus University, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PADME1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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