Pancreatic Islet Mass in Pregnancy in Type 1 Diabetes
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Purpose
Type 1 diabetic women have a decrease in insulin requirements during early pregnancy. Preliminary evidence suggests this decrease may be secondary to the regeneration of pancreatic B-cells during pregnancy During the second and third trimesters, insulin requirements in Type 1 diabetic women progressively increase until approximately 36 weeks gestation at which time there is a plateau, and frequently, a drop in insulin requirements. We hypothesize that there is regeneration of pancreatic islet cell mass in Type 1 diabetic women during pregnancy. In a cross-sectional study, we will use the acute insulin c-peptide response to arginine to determine if pancreatic islet mass increases at 12 and 36 weeks gestation. Type 1 diabetic women who are not pregnant, who are at 12 and 36 weeks gestation, and who are 6 weeks post-partum will undergo an intravenous arginine tolerance test following an overnight fast. If we find that there is regeneration of beta cells it opens the possibility that therapy may be directed to the same end for people with Type 1 diabetes.
| Condition |
|---|
|
Type 1 Diabetes Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Pancreatic Islet Mass in Pregnancy - Pilot Study |
- The documentation of Cpeptide in women with type 1 diabetes who are pregnant [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma Samples kept for batching of antibody assays
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2012 |
| Groups/Cohorts |
|---|
|
1
Pregnant (12 - 16 wks gestation) women with Type 1 diabetes
|
|
2
Pregnant women (34-38 wks gestation) with Type 1 diabetes
|
|
3
Post partum women with Type 1 diabetes
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|
4
Non pregnant women with Type 1 diabetes
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pregnant women with Type 1 diabetes
Inclusion Criteria:
- Signed informed consent
- Females with Type 1 diabetes for at least 5 years
- Diabetes onset < 21 years
- Lean at diabetes onset
- Insulin required from diagnosis
- Willing to undergo intravenous arginine tolerance tests
Exclusion Criteria:
- Inability to provide informed consent
- Any medical condition that would preclude safe conduct of the intravenous arginine
- A family history which includes three generations of family members with the diagnosis of diabetes mellitus
- Women with elevated serum creatinine as arginine is excreted by the kidneys.
Contacts and Locations| Contact: Edmond A Ryan, MD | 780 407 3636 | edmond.ryan@ualberta.ca |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2S2 | |
| Contact: Edmond A Ryan, MD 780 407 3636 edmond.ryan@ualberta.ca | |
| Principal Investigator: Edmond A Ryan, MD | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Edmond A Ryan, MD 780 407 3636 Edmond.Ryan@Ualberta.ca | |
| Principal Investigator: Edmond A Ryan, MD | |
| University of Alberta | Enrolling by invitation |
| Edmonton, Alberta, Canada, T6G 2S2 | |
| Principal Investigator: | Edmond A Ryan, MD | University of Alberta |
More Information
No publications provided
| Responsible Party: | Edmond A Ryan, Professor, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00548522 History of Changes |
| Other Study ID Numbers: | UAHREB4503 |
| Study First Received: | October 23, 2007 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Alberta:
|
Type 1 Diabetes Pregnancy Islet Mass C-peptide |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013