Status:
WITHDRAWN
Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
Lead Sponsor:
Sansum Diabetes Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This is a randomized, double-masked, placebo-controlled, single-center study to evaluate stimulated C-peptide secretion after exogenous administration of mild immunosuppression and growth-promoting fa...
Detailed Description
The primary objective of this study is to determine whether women with preexisting T1DM who showed a decline in insulin requirement, defined as a decrease in insulin requirement of 25% or more, or a d...
Eligibility Criteria
Inclusion
- Female aged 18 years or older with T1DM and a documented history of at least one of the following:
- Decrease in insulin requirement with no other medically determined reason
- Detectable C-peptide
- Free of systemic corticosteroid use within 3 months before study entry.
- Stable weight (±10%)
- Stable diet and exercise
- Stable insulin requirement (\<20% variability in insulin does in the 2 weeks prior to screening)Normal renal function as measured by an estimated glomerular filtration rate (simple MDRD)
- Negative pregnancy test and not planning to become pregnant during the study period. The subject must be willing to use an effective nonhormonal method of birth control during the study.
- Able to provide written informed consent.
Exclusion
- Diagnosis of type 2 diabetes.
- Abnormal thyroid function (thyroid-stimulating hormone \[TSH\] and free thyroxine \[FT4\] test results) defined as TSH \<0.4mIU/L or TSH\>4.5mIU/L or Free T4 \<0.6ng/dL or Free T4\>1.6ng/dL.
- Abnormal renal function, as defined by serum creatinine greater than 1.2 mg/dL
- Any medical condition that, in the opinion of the investigator, yields the subject not suitable for study participation, including history of stroke, cancer, hypercoagulable problems, risk for deep vein thrombosis, and other unstable hormonal conditions, or Addison's disease or growth hormone deficiency.
- Currently treated with systemic steroids, hydrocortisone, growth hormone, or immunomodulatory medications
- Currently lactating.
- Pregnant within the last 9 months.
- Menopausal
- Taking hormonal therapy
- Known hypersensitivity to any of the medications used in this study or any component of the formulation.
- Known eating disorder
- History of phlebitis
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01265017
Start Date
July 1 2012
End Date
June 1 2020
Last Update
April 18 2018
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105