Diabetes Mellitus, Type 2NCT04924504
Mechanisms Behind Severe Insulin Resistance During Pregnancy in Women With Glucose Metabolic Disorders (SIR-MET)
An observational study of Diabetes Mellitus, Type 2 and Gestational Diabetes, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of this study is to describe the metabolic changes during pregnancy in women with type 2 diabetes or gestational diabetes in order to detect the pathophysiological mechanisms behind severe insulin resistance during pregnancy as well as the short- and long term consequences for mother and child. 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
- Diabetes Mellitus, Type 2, Gestational Diabetes, Overweight and Obesity
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population consist of pregnant women followed at The Department of Gynaecology and Obstetrics at Aarhus University Hospital or Aalborg University Hospital. Cases are diagnosed with gestational diabetes or pregestational type 2 diabetes and are treated with a total daily insulin dose >= 100 units/day. Controls are either healthy without pregestational or gestational diabetes or diagnosed with gestational diabetes or pregestational type 2 diabetes and are treated with a total daily insulin dose <= 75 units/day
Who may be able to join
- Pregnant women at The Department of Gynaecology and Obstetrics at Aarhus University Hospital or Aalborg University Hospital.
- Women have to be in 1 of 3 categories: Healthy without pregestational or gestational diabetes, type 2 diabetes treated with insulin or gestational diabetes treated with insulin.
Who cannot join
- Age < 18 years
- Not able to read and understand danish
- Previous bariatric surgery
- Treatment with systemic corticosteroids
- Other severe chronic diseases such as inflammatory bowel disease, cystic fibrosis and type 1 diabetes
Trial locations and contacts
2 sites in 1 country.
Per G Ovesen, Prof., MD contact
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9100
Anne W Sørensen, M.D., +45 93 50 80 69, anns@rn.dk
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Anna S Koefoed, M.D., +45 25 32 35 38, annask@clin.au.dk
Per G Ovesen, Prof., M.D., perovese@rm.dk
About this study
The aim of this study is to describe the metabolic changes during pregnancy in women with type 2 diabetes or gestational diabetes in order to detect the pathophysiological mechanisms behind severe insulin resistance during pregnancy as well as the short- and long term consequences for mother and child.
Included pathophysiological mechanisms potentially associated with severe insulin resistance are: Maternal hormonal, inflammatory and metabolic markers in the blood, as well as the level, content and bioactivity of exosomes and genetic variants associated with overweight and diabetes.
Read more
In addition to the analysis on maternal blood, the same analysis will be performed on umbilical cord blood in order to determine the correlation between markers associated with insulin sensitivity in maternal and umbilical blood. Furthermore, fetal metabolic changes influence on fetal growth and development will be evaluated. Postpartum, the breast milk will also be examined for metabolic active substances that could influence the newborns growth and metabolism.
Investigating one potential short-term consequence of diabetes during pregnancy, the association between insulin resistance and structural and functional changes in the placenta will be examined as well as the consequences of such changes on fetal growth and development.
Investigating one potential long-term consequence of diabetes during pregnancy, the association between treatment with high doses of insulin during pregnancy and the future risk of developing cardiovascular diseases and heart failure will be examined.
Read the detailed description
This is a prospective observational study including app. 24 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg and Aarhus University Hospital.
The study includes 8 healthy women without pregestational or gestational diabetes, 8 women with gestational diabetes or type 2 diabetes with a total daily insulin dose <= 75 units/day and 8 women with gestational diabetes or type 2 diabetes with a total daily insulin dose >= 100 units/day.
There are three study days: One in gestational week 28-36 (day 1), one during labour (day 2) and one 6 months postpartum (day 3).
Hormonal profiles and inflammatory markers will be measured at all three study days. During labour both maternal and umbilical blood will be collected. The blood sample analysis will include HbA1c, glukose, insulin, C-peptid, human anti-insulin antibody, lipid profile, liver enzymes, creatinine, FGF-21, TSH, Cortisol, human chorionic gonadotropin, estradiol, progesterone, SHBG, prolactin, human placental lactogen, placental growth hormone, PAPP-A, sFlt-1, PP13, IGF-1, IGF-BP's, Leptin, Adiponectin, 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. Furthermore, whole genome analysis will be applied to find genetic variants associated with overweight and diabetes (genetic analysis will not be performed on umbilical cord blood). Insulin sensitivity will be estimated using the homeostasis model assessment, IS-HOMA, based on fasting C-peptid and glucose concentrations.
In addition to the blood samples, the following examinations will be performed at day 1:
- Height, weight and bioelectrical impedance analysis
- Urine sample (Albumin-to-creatinine ratio)
- Blood pressure and 24-hour ambulatory blood pressure monitoring
- Central arterial pressure waveform analysis (SphygmoCor)
- Echocardiography
- Fetal ultrasound
- MRI scan of the placenta and heart
In addition to the blood samples, the following examinations will be performed at day 2:
- Placenta will be collected for a postpartum histopathological examination
- Breast milk (analyzed for lipid profile, leptin, adiponectin, prolactin, prolactin-binding protein, oxytocin, ghrelin, insulin, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM, CD163 and untargeted metabolomics)
- Skinfold measurement of the newborn with a caliper
In addition to the blood samples, the following examinations will be performed at day 3:
- Height, weight and bioelectrical impedance analysis
- Urine sample (Albumin-to-creatinine ratio)
- Blood pressure and 24-hour ambulatory blood pressure monitoring
- Central arterial pressure waveform analysis (SphygmoCor)
- Echocardiography
- Breast milk (analyzed for lipid profile, leptin, adiponectin, prolactin, prolactin-binding protein, oxytocin, ghrelin, insulin, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM, CD163 and untargeted metabolomics)
- Conditions
- Diabetes Mellitus, Type 2, Gestational Diabetes, Overweight and Obesity, Pregnancy in Diabetic, Insulin Resistance, Insulin Sensitivity
- Being tested
- No interventions
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational, Overweight, Obesity, Pregnancy in Diabetics, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Type A | Healthy pregnant women without pregestational or gestational diabetes Receives: Other: No interventions | |
| Type B | Pregnant women with type 2 diabetes or gestational diabetes with a total daily insulin dose <= 75 units/day Receives: Other: No interventions | |
| Type C | Pregnant women with type 2 diabetes or gestational diabetes with a total daily insulin dose >= 100 units/day Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between insulin sensitivity Versus structural and functional changes in the placenta
Structural and functional changes in the placenta will be evaluated using a functional T2-weighted MRI scan. Specifically the function of placenta will be evaluated using a T2-value. Furthermore, structural and functional changes in the placenta will be evaluated through a postpartum histopathological examination of the placenta. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting C-peptid and glucose concentrations.
Measured: Gestational week 28-36
Secondary outcomes (12)
Association between structural and functional changes in the placenta Versus fetal growth and development
Structural and functional changes in the placenta will be evaluated using a functional T2-weighted MRI scan. Specifically the function of placenta will be evaluated using a T2-value. Furthermore, structural and functional changes in the placenta will be evaluated through a postpartum histopathological examination of the placenta. Fetal growth will be evaluated through a fetal ultrasound measuring biometric parameters and bloodflow.
Measured: Gestational week 28-36
Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers
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, Human Placental Growth Hormone, PAPP-A, sFlt-1, PP13 and human anti-insulin antibody.
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.
Measured: Gestational week 28-36, at labour and 6 months postpartum
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity
Association between the metabolic, hormonal and inflammatory markers listed as Outcome 2 and the Insulin sensitivity. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting C-peptid and glucose concentrations.
Measured: Gestational week 28-36, at labour and 6 months postpartum
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers in maternal blood Versus the serum or plasma concentrations of the same markers in umbilical cord blood
Association between the metabolic, hormonal and inflammatory markers listed as Outcome 2 in maternal and umbilical cord blood
Measured: At labour
Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma.
Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.
Measured: Gestational week 28-36, at labour and 6 months postpartum
Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity
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 C-peptid and glucose concentrations.
Measured: Gestational week 28-36, at labour and 6 months postpartum
Association between the level, content and bioactivity of exosomes in serum and plasma in maternal blood Versus the level, content and bioactivity of exosomes in serum and plasma in umbilical cord blood
Exosomes will be isolated and profiling of the content will be performed using SWATH mass spectrometry and miRNA sequencing.
Measured: At labour
Association between genetic variants related to overweight and diabetes Versus Insulin sensitivity
Genetic variants will be examined using whole genome analysis (Illumina Novaseq System). Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting C-peptid and glucose concentrations.
Measured: Gestational week 28-36
Changes from baseline in body weight and body composition.
Body weight measured in kilograms. Body composition: Body fat percentage and muscle mass
Measured: Gestational week 28-36 and 6 months postpartum
Changes from baseline in 24-hour ambulatory blood pressure (systolic and diastolic)
Blood pressure includes the measurement of both systolic and diastolic blood pressure (mmHg).
Measured: Gestational week 28-36 and 6 months postpartum
Changes from baseline in cardiac function
Cardiac function will be evaluated through an echocardiography and a MRI scan of the heart
Measured: Gestational week 28-36 and 6 months postpartum
Changes from baseline in the central aortic pressure waveform
Central aortic pressure waveform will be evaluated through a noninvasive measurement with SphygmoCor technology
Measured: Gestational week 28-36 and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Anna S Koefoed, MD, Principal investigator, Aarhus University, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924504
- Sponsor's protocol ID
- PADME
- Status last verified
- Nov 2022
- First submitted
- 7 Jun 2021
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Behind Severe Insulin Resistance During Pregnancy in Women With Glucose Metabolic Disorders (SIR-MET)
- ClinicalTrials.gov ID
- NCT04924504
- Acronym / sponsor ID
- PADME
- Conditions
- Diabetes Mellitus, Type 2, Gestational Diabetes, Overweight and Obesity, Pregnancy in Diabetic, Insulin Resistance, Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, The University of Queensland
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jun 2021 (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.
The aim of this study is to describe the metabolic changes during pregnancy in women with type 2 diabetes or gestational diabetes in order to detect the pathophysiological mechanisms behind severe insulin resistance during pregnancy as well as the short- and long term consequences for mother and child.
Included pathophysiological mechanisms potentially associated with severe insulin resistance are: Maternal hormonal, inflammatory and metabolic markers in the blood, as well as the level, content and bioactivity of exosomes and genetic variants associated with overweight and diabetes.
In addition to the analysis on maternal blood, the same analysis will be performed on umbilical cord blood in order to determine the correlation between markers associated with insulin sensitivity in maternal and umbilical blood. Furthermore, fetal metabolic changes influence on fetal growth and development will be evaluated. Postpartum, the breast milk will also be examined for metabolic active substances that could influence the newborns growth and metabolism.
Investigating one potential short-term consequence of diabetes during pregnancy, the association between insulin resistance and structural and functional changes in the placenta will be examined as well as the consequences of such changes on fetal growth and development.
Investigating one potential long-term consequence of diabetes during pregnancy, the association between treatment with high doses of insulin during pregnancy and the future risk of developing cardiovascular diseases and heart failure will be examined.
Detailed description
This is a prospective observational study including app. 24 pregnant women from the outpatient clinics at Department of Obstetrics and Gynecology at Aalborg and Aarhus University Hospital.
The study includes 8 healthy women without pregestational or gestational diabetes, 8 women with gestational diabetes or type 2 diabetes with a total daily insulin dose <= 75 units/day and 8 women with gestational diabetes or type 2 diabetes with a total daily insulin dose >= 100 units/day.
There are three study days: One in gestational week 28-36 (day 1), one during labour (day 2) and one 6 months postpartum (day 3).
Hormonal profiles and inflammatory markers will be measured at all three study days. During labour both maternal and umbilical blood will be collected. The blood sample analysis will include HbA1c, glukose, insulin, C-peptid, human anti-insulin antibody, lipid profile, liver enzymes, creatinine, FGF-21, TSH, Cortisol, human chorionic gonadotropin, estradiol, progesterone, SHBG, prolactin, human placental lactogen, placental growth hormone, PAPP-A, sFlt-1, PP13, IGF-1, IGF-BP's, Leptin, Adiponectin, 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. Furthermore, whole genome analysis will be applied to find genetic variants associated with overweight and diabetes (genetic analysis will not be performed on umbilical cord blood). Insulin sensitivity will be estimated using the homeostasis model assessment, IS-HOMA, based on fasting C-peptid and glucose concentrations.
In addition to the blood samples, the following examinations will be performed at day 1:
- Height, weight and bioelectrical impedance analysis
- Urine sample (Albumin-to-creatinine ratio)
- Blood pressure and 24-hour ambulatory blood pressure monitoring
- Central arterial pressure waveform analysis (SphygmoCor)
- Echocardiography
- Fetal ultrasound
- MRI scan of the placenta and heart
In addition to the blood samples, the following examinations will be performed at day 2:
- Placenta will be collected for a postpartum histopathological examination
- Breast milk (analyzed for lipid profile, leptin, adiponectin, prolactin, prolactin-binding protein, oxytocin, ghrelin, insulin, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM, CD163 and untargeted metabolomics)
- Skinfold measurement of the newborn with a caliper
In addition to the blood samples, the following examinations will be performed at day 3:
- Height, weight and bioelectrical impedance analysis
- Urine sample (Albumin-to-creatinine ratio)
- Blood pressure and 24-hour ambulatory blood pressure monitoring
- Central arterial pressure waveform analysis (SphygmoCor)
- Echocardiography
- Breast milk (analyzed for lipid profile, leptin, adiponectin, prolactin, prolactin-binding protein, oxytocin, ghrelin, insulin, hs-CRP, IL-6, IL-10, IL-1α, IFN-ɣ, TNF-α, ICAM1, VCAM, CD163 and untargeted metabolomics)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type A | – | Other: No interventionsHealthy pregnant women without pregestational or gestational diabetes |
| Type B | – | Other: No interventionsPregnant women with type 2 diabetes or gestational diabetes with a total daily insulin dose <= 75 units/day |
| Type C | – | Other: No interventionsPregnant women with type 2 diabetes or gestational diabetes with a total daily insulin dose >= 100 units/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of pregnant women followed at The Department of Gynaecology and Obstetrics at Aarhus University Hospital or Aalborg University Hospital. Cases are diagnosed with gestational diabetes or pregestational type 2 diabetes and are treated with a total daily insulin dose >= 100 units/day. Controls are either healthy without pregestational or gestational diabetes or diagnosed with gestational diabetes or pregestational type 2 diabetes and are treated with a total daily insulin dose <= 75 units/day
Key inclusion criteria (2 listed)
- Pregnant women at The Department of Gynaecology and Obstetrics at Aarhus University Hospital or Aalborg University Hospital.
- Women have to be in 1 of 3 categories: Healthy without pregestational or gestational diabetes, type 2 diabetes treated with insulin or gestational diabetes treated with insulin.
Key exclusion criteria (5 listed)
- Age < 18 years
- Not able to read and understand danish
- Previous bariatric surgery
- Treatment with systemic corticosteroids
- Other severe chronic diseases such as inflammatory bowel disease, cystic fibrosis and type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | Type A, Type B, Type C |
Primary outcome
Association between insulin sensitivity Versus structural and functional changes in the placenta
Time frame: Gestational week 28-36
Structural and functional changes in the placenta will be evaluated using a functional T2-weighted MRI scan. Specifically the function of placenta will be evaluated using a T2-value. Furthermore, structural and functional changes in the placenta will be evaluated through a postpartum histopathological examination of the placenta. Insulin sensitivity will be estimated using the homeostasis model assessment (HOMA-IR) based on fasting C-peptid and glucose concentrations.
12 secondary outcomes
Association between structural and functional changes in the placenta Versus fetal growth and development
Time frame: Gestational week 28-36
Changes from baseline in serum or plasma concentration of metabolic, hormonal and inflammatory markers
Time frame: Gestational week 28-36, at labour and 6 months postpartum
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers Versus Insulin sensitivity
Time frame: Gestational week 28-36, at labour and 6 months postpartum
Assocation between the serum or plasma concentration of metabolic, hormonal and inflammatory markers in maternal blood Versus the serum or plasma concentrations of the same markers in umbilical cord blood
Time frame: At labour
Changes from baseline in the level, content and bioactivity of exosomes in serum and plasma.
Time frame: Gestational week 28-36, at labour and 6 months postpartum
Association between the level, content and bioactivity of exosomes in serum and plasma Versus Insulin sensitivity
Time frame: Gestational week 28-36, at labour and 6 months postpartum
Association between the level, content and bioactivity of exosomes in serum and plasma in maternal blood Versus the level, content and bioactivity of exosomes in serum and plasma in umbilical cord blood
Time frame: At labour
Association between genetic variants related to overweight and diabetes Versus Insulin sensitivity
Time frame: Gestational week 28-36
Changes from baseline in body weight and body composition.
Time frame: Gestational week 28-36 and 6 months postpartum
Changes from baseline in 24-hour ambulatory blood pressure (systolic and diastolic)
Time frame: Gestational week 28-36 and 6 months postpartum
Changes from baseline in cardiac function
Time frame: Gestational week 28-36 and 6 months postpartum
Changes from baseline in the central aortic pressure waveform
Time frame: Gestational week 28-36 and 6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- 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. This study is not recruiting at the moment.
Per G Ovesen, Prof., MD contact
Anna S Koefoed, MD principal investigator
Aarhus University, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Gestational Diabetes, run by University of Aarhus at 2 sites in Denmark.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna S Koefoed, MD (+45 93 50 80 69, annask@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between insulin sensitivity Versus structural and functional changes in the placenta (time frame: Gestational week 28-36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2022.