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• Status: Withdrawn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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sansum Diabetes Research Institute; William Sansum Diabetes Center
• Treatments: Cortisol succinate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Hormones; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Medroxyprogesterone; Medroxyprogesterone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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