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Sponsored by: |
University of Alberta |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00548522 |
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 |
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Type 1 Diabetes Pregnancy |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | Pancreatic Islet Mass in Pregnancy - Pilot Study |
Plasma Samples kept for batching of antibody assays
Estimated Enrollment: | 30 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | November 2009 |
Groups/Cohorts |
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1
Pregnant (12 - 16 wks) women with Type 1 diabetes
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2
Pregnant women (34-38 wks) with Type 1 diabetes
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Post partum women with Type 1 diabetes
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Non pregnant women with Type 1 diabetes
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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:
Exclusion Criteria:
Contact: Edmond A Ryan, MD | 780 407 3636 | edmond.ryan@ualberta.ca |
Contact: Judy Germsheid, RN | 780 407 8630 | judyg@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 | |
Contact: Judy Germsheid, RN 780 407 8630 judyg@ualberta.ca | |
Principal Investigator: Edmond A Ryan, MD | |
Sub-Investigator: Carmen Young, MD | |
University of Alberta Hospital | Recruiting |
Edmonton, Alberta, Canada, T6G 2B7 | |
Contact: Edmond A Ryan, MD 780 407 3636 Edmond.Ryan@Ualberta.ca | |
Contact: Judy Germsheid, RN 780 407 8630 judyg@Ualberta.ca | |
Principal Investigator: Edmond A Ryan, MD |
Principal Investigator: | Edmond A Ryan, MD | University of Alberta |
Responsible Party: | University of Alberta ( Edmond A Ryan ) |
Study ID Numbers: | UAHREB4503 |
Study First Received: | October 23, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00548522 History of Changes |
Health Authority: | Canada: Health Canada |
Type 1 Diabetes Pregnancy Islet Mass C-peptide |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |