Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
Status:
Withdrawn
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
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 factors to women with preexisting T1DM who had a decline in insulin
requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be
enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a
parallel group design.
Participation for individual subjects will consist of an initial Screening Visit, a 2-week
baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at
the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment
discontinuation.
Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8
hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25
mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).
Phase:
Phase 1
Details
Lead Sponsor:
Sansum Diabetes Research Institute William Sansum Diabetes Center