Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT00014768
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2001-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
Sponsor:
National Center for Research Resources (NCRR)
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2002-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis.
II. Determine glucose tolerance during each trimester of pregnancy in these women.
III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein turnover and hepatic glucose production in these women.
V. Determine resting energy expenditure in these women.
II. Determine glucose tolerance during each trimester of pregnancy in these women.
III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein turnover and hepatic glucose production in these women.
V. Determine resting energy expenditure in these women.
Detailed Description:
PROTOCOL OUTLINE: Patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1. Patients undergo an indirect calorimetry over 20 minutes on day 2. Patients receive stable-labeled leucine and stable-labeled glucose IV over 3 hours followed by insulin and glucose IV over 4-4.5 hours on day 2 using the hyperinsulinemic euglycemic clamp technique.
Blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. Hepatic glucose production is measured by mass spectrophotometry.
Patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy.
Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum.
Blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. Hepatic glucose production is measured by mass spectrophotometry.
Patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy.
Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UUSOM-IRB-7922-00 | None | None | View |