ABSTRACT
OBJECTIVE: To assess the biological safety of four hormone replacement treatment (HRT) combinations in women with non insulin dependent diabetes mellitus (NIDDM) or impaired glucose tolerance (IGT). SUBJECTS AND METHODS: Randomized, double-blind, placebo-controlled trial to analyze the variation of fibrinogen, factor VII, PAI1, and TG blood levels in women (n=99), with NIDDM or IGT, receiving a 3-month course of either oral oestradiol (1 or 2 mg) combined with Chlormadinone Acetate 5 mg, or transdermal oestradiol 50 microg/24 h in association with Norethisterone Acetate (11.2 or 22.4 mg), or placebo. Follow-up lasted 3 months. RESULTS: Ninety nine patients, mean age 56 years (SD 5), mean diabetes duration 7 years (S.D. 7), mean glycated hemoglobin (7.3%) were enrolled. There was no significant difference between the groups for any of the primary hemostasis criteria (n=77). Triglycerides (TG) variation significantly differed between groups, P=0.01, from -21% in the large patch group, to +22% in the placebo group (n=82). Treatment administration routes did not significantly differ for any of the criteria. There was a significant difference in the total cholesterol variation between groups, from +8.7% in the placebo group to -10.8% in the oral 1 mg group (P=0.001). CONCLUSION: The treatments had no highly deleterious effect in these patients with NIDDM or with IGT. Long-term trials can be performed with such patients, and an hormone treatment can be prescribed to relieve symptoms. Since these patients had a well-controlled NIDDM, results might be different in less well-controlled diabetes. The data do not support the hypothesis of an impaired oestrogen effect in patients with NIDDM.
Subject(s)
Diabetes Mellitus, Type 2/blood , Estrogens/therapeutic use , Glucose Intolerance/blood , Hormone Replacement Therapy/methods , Biomarkers/blood , Chlormadinone Acetate/administration & dosage , Double-Blind Method , Drug Therapy, Combination , Estrogens/administration & dosage , Estrogens/adverse effects , Female , Hormone Replacement Therapy/adverse effects , Humans , Informed Consent , Middle Aged , Norethindrone/administration & dosage , Norethindrone/analogs & derivatives , Norethindrone Acetate , Postmenopause/bloodABSTRACT
Plasma testosterone; androstenedione and DHA were measured by radio-immunoassay before (J1) under (J2) and 24-hour after (J3) oral metyrapone (4,5 g) in 10 normal and 12 hirsute women. Although individual values were dispersed, hirsute women, as a group, had significantly higher values at each time for each steroid. Hirsute women with normal basal T had normal T and A values for J1, J2, J3; while these with elevated basal T had elevated T and A value for all samples. Plasma DHEA was elevated in the two groups, before, under and after métopirone.
Subject(s)
Androstenedione/blood , Dehydroepiandrosterone/blood , Hirsutism/blood , Metyrapone/administration & dosage , Testosterone/blood , Administration, Oral , Female , HumansABSTRACT
Blood testosterone (T), androstenedione (A) and dehydroisoandrosterone (DHA) were simultaneously measured, using radioimmunoassay, in six healthy (control) females and eight various subjects, before (J1), during (J2) and after (J3) metopirone administration. The variation pattern of each androgen is different during the test. The mean value of each androgen at each time, point and the percentage decrease between J2 and J3 related to J2 are considered. Each step of the test (increase and decrease) is discussed with reference to published data and variations of response obeserved in the eight non control subjects.
