Pancreatic Islet Mass in Pregnancy in Type 1 Diabetes

This study has been terminated.
(Difficulty in finding staff to help with study)
Sponsor:
Information provided by (Responsible Party):
Edmond A Ryan, University of Alberta
ClinicalTrials.gov Identifier:
NCT00548522
First received: October 23, 2007
Last updated: May 20, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: August 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
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
Study Population

Pregnant women with Type 1 diabetes

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548522

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2S2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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: May 20, 2014
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 July 22, 2014