Pancreatic Islet Mass in Pregnancy in Type 1 Diabetes

NCT00548522 | Terminated

• 1 other identifier: UAHREB4503
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes; Pregnancy

Keywords

Type 1 Diabetes; Pregnancy; Islet Mass; C-peptide

Outcome Measures

Primary Outcomes (1)

• The documentation of Cpeptide in women with type 1 diabetes who are pregnant

  1 year

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with Type 1 diabetes

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2S2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Samples kept for batching of antibody assays

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Edmond A Ryan, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

CA (2)