Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2012 |
| End Date: | June 2015 |
| Contact: | Lois Jovanovic, MD |
| Email: | ljovanovic@sansum.org |
| Phone: | 805-682-7638 |
Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM
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).
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).
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 decrease deemed to be clinically significant by the investigator, with no
other medically determined reason, or who had detectable C-peptide during a previous
pregnancy will show a change in stimulated C peptide response when not pregnant and treated
with exogenous pregnancy-related hormones and growth factors (Estradiol,
medroxyprogesterone, hydrocortisone, GH) for 6 weeks.
The secondary objectives of this study are as follows:
- Determine whether the study treatment leads to a change in T1DM autoantibodies between
Baseline and Week 6
- Determine the percentage of subjects experiencing a clinically significant decline in
total daily insulin requirement at Week 6, defined as a 25% decrease from Baseline
- Descriptively evaluate the association between serum levels of growth hormone,
cortisol, and prolactin and changes in C-peptide levels
- Evaluate the safety of administration of the study treatments compared with placebo, as
measured by blood pressure, pulse, weight change, blood glucose, and adverse events
(AEs)
showed a decline in insulin requirement, defined as a decrease in insulin requirement of 25%
or more, or a decrease deemed to be clinically significant by the investigator, with no
other medically determined reason, or who had detectable C-peptide during a previous
pregnancy will show a change in stimulated C peptide response when not pregnant and treated
with exogenous pregnancy-related hormones and growth factors (Estradiol,
medroxyprogesterone, hydrocortisone, GH) for 6 weeks.
The secondary objectives of this study are as follows:
- Determine whether the study treatment leads to a change in T1DM autoantibodies between
Baseline and Week 6
- Determine the percentage of subjects experiencing a clinically significant decline in
total daily insulin requirement at Week 6, defined as a 25% decrease from Baseline
- Descriptively evaluate the association between serum levels of growth hormone,
cortisol, and prolactin and changes in C-peptide levels
- Evaluate the safety of administration of the study treatments compared with placebo, as
measured by blood pressure, pulse, weight change, blood glucose, and adverse events
(AEs)
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
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