21-hydroxylase; DefectGLUCODEXNCT01367106
Effects of "in UTERO" Exposure to Glucocorticoids
A study testing Euglycemic hyperinsulinemic clamp in people with 21-hydroxylase; Defect, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 21-hydroxylase; Defect
- What is being tested?
- Euglycemic hyperinsulinemic clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2012to Jun 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years Aged
- Males
- Women of childbearing age with a reliable and effective contraception for over 2 months
- Taking dexamethasone between the 6th and the 24th week of gestation by the mother with bloc 21-hydroxylase or normal pregnancy for control subjects
- Normal blood pressure and heart rate measured at rest: systolic blood pressure <= 150 mmHg, diastolic blood pressure <= 90 mmHg, heart rate between 55 and 90 beats/mn.
- Normal laboratory tests or not clinically significant abnormality NFS, platelets PT, aPTT, fibrin TP, TCA, Serum electrolytes, urea, creatinine Uric acid Triglycerides, total cholesterol, HDL cholesterol
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- Fating bood glucose <= 6.9 mmol/l (exclusion criteria for diabetes from the American Diabetes Association) during the OGTT.
- Negative blood HCG
- Accepting the constraints of the protocol and had signed informed and free consent.
- Affiliated to the Social Security.
Who cannot join
- Affected offspring of 21-hydroxylase enzyme block
- Taking dexamethasone until pregnancy term by the mother of the subject
- Type 2 diabetes in one of the two parents and/or 1 of the 4 grandparents
- Pregnancy, Breastfeeding
- Body Mass Index (weight/height2)> 50 kg/m2
- Poisoning smoking (>10 cigarettes per day, whatever the duration of intoxication)
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- Any drug taken apart from minor analgesics (aspirin, paracetamol) for less than 8 days at the inclusion and oral contraception
- Taking recent (less than 3 months) glucocorticoids either taken orally, by inhalation or percutaneously
- Current infections or recent infections (<10 days)
- Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
- Having donated blood or participated in a trial within 2 months preceding their inclusion
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.
Read the detailed description
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult 23 subjects of exposed offspring will be compared to 23 controls
- Conditions
- 21-hydroxylase; Defect
- Being tested
- Euglycemic hyperinsulinemic clamp
- Keywords
- offspring of 21-hydroxylase enzyme block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euglycemic hyperinsulinemic clampProcedure or surgery
Euglycemic hyperinsulinemic clamp will be performed at day 2
| Study group | Role | What they receive |
|---|---|---|
| exposed offspring | Experimental | Not described Receives: Procedure: Euglycemic hyperinsulinemic clamp |
| controls | Other | Not described Receives: Procedure: Euglycemic hyperinsulinemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow
Measured: 3 days
Secondary outcomes (3)
Insulin Sensitivity
Measured: 3 days
Flow measurement of insulin secretory response to intravenous glucose
Measured: 3 days
Measurement of the secretion of insulin and glucagon in response to arginine
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startNov 2012
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 21-hydroxylase; DefectStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François GAUTIER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367106
- Sponsor's protocol ID
- P081209
- Acronym
- GLUCODEX
- Status last verified
- Dec 2017
- First submitted
- 24 May 2011
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Riveline JP, Baz B, Nguewa JL, Vidal-Trecan T, Ibrahim F, Boudou P, Vicaut E, Brac de la Perriere A, Fetita S, Breant B, Blondeau B, Tardy-Guidollet V, Morel Y, Gautier JF. Exposure to Glucocorticoids in the First Part of Fetal Life is Associated with Insulin Secretory Defect in Adult Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz145. doi: 10.1210/clinem/dgz145.
PubMed 31665349
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
- ClinicalTrials.gov ID
- NCT01367106
- Acronym / sponsor ID
- GLUCODEX / P081209
- Conditions
- 21-hydroxylase; Defect
- Keywords
- offspring of 21-hydroxylase enzyme block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 6 Jun 2011 (estimated)
- 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 main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.
Detailed description
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult 23 subjects of exposed offspring will be compared to 23 controls
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed offspring | Experimental | Procedure: Euglycemic hyperinsulinemic clamp |
| controls | Other | Procedure: Euglycemic hyperinsulinemic clamp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Over 18 years Aged
- Males
- Women of childbearing age with a reliable and effective contraception for over 2 months
- Taking dexamethasone between the 6th and the 24th week of gestation by the mother with bloc 21-hydroxylase or normal pregnancy for control subjects
- Normal blood pressure and heart rate measured at rest: systolic blood pressure <= 150 mmHg, diastolic blood pressure <= 90 mmHg, heart rate between 55 and 90 beats/mn.
Key exclusion criteria (11 listed)
- Affected offspring of 21-hydroxylase enzyme block
- Taking dexamethasone until pregnancy term by the mother of the subject
- Type 2 diabetes in one of the two parents and/or 1 of the 4 grandparents
- Pregnancy, Breastfeeding
- Body Mass Index (weight/height2)> 50 kg/m2
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 |
|---|---|---|
| Euglycemic hyperinsulinemic clampEuglycemic hyperinsulinemic clamp will be performed at day 2 | Procedure or surgery | controls, exposed offspring |
Primary outcome
Glucose Tolerance
Time frame: 3 days
the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow
3 secondary outcomes
Insulin Sensitivity
Time frame: 3 days
Flow measurement of insulin secretory response to intravenous glucose
Time frame: 3 days
Measurement of the secretion of insulin and glucagon in response to arginine
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Derived from this study: PubMed 31665349Riveline JP, Baz B, Nguewa JL, Vidal-Trecan T, Ibrahim F, Boudou P, Vicaut E, Brac de la Perriere A, Fetita S, Breant B, Blondeau B, Tardy-Guidollet V, Morel Y, Gautier JF. Exposure to Glucocorticoids in the First Part of Fetal Life is Associated with Insulin Secretory Defect in Adult Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz145. doi: 10.1210/clinem/dgz145.
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.
Jean-François GAUTIER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euglycemic hyperinsulinemic clamp in people with 21-hydroxylase; Defect, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 10 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: status not confirmed, as of the sponsor's last update on 21 Dec 2017. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Tolerance (time frame: 3 days). 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 NCT01367106, which also lists 1 linked publication.
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 21 Dec 2017.