Effects of in UTERO Exposure to Glucocorticoids

Study of the Effects in Carbohydrate Metabolism and Renal Function of in UTERO Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367106

Acronym

GLUCODEX

Enrollment

Registered

2011-06-06

Start date

2012-11-30

Completion date

2018-06-30

Last updated

2017-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

21-hydroxylase; Defect

Keywords

offspring of 21-hydroxylase enzyme block

Brief 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.

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

Interventions

PROCEDUREEuglycemic hyperinsulinemic clamp

Euglycemic hyperinsulinemic clamp will be performed at day 2

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 * 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.

Design outcomes

Primary

Measure	Time frame	Description
Glucose Tolerance	3 days	the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow

Secondary

Measure	Time frame
Insulin Sensitivity	3 days
Flow measurement of insulin secretory response to intravenous glucose	3 days
Measurement of the secretion of insulin and glucagon in response to arginine	3 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026