Postmenopause hormone treatment in women with NIDDM or impaired glucose tolerance: the MEDIA randomized clinical trial.

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.

• Authors: C Cornu, C Mercier, P Ffrench, C Bully, M Pugeat, P Cousin, J P Riou, L Bajart, J Orgiazzi, C Pommet-Nicot, P Darsy, J P Boissel, F Berthezène
• Journal: Maturitas (Maturitas) Vol. 37 Issue 2 Pg. 95-104 (Dec 29 2000) ISSN: 0378-5122 [Print] Ireland
• PMID: 11137328 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Estrogens
• Chlormadinone Acetate
• Norethindrone Acetate
• Norethindrone

Topics

• Biomarkers (blood)
• Chlormadinone Acetate (administration & dosage)
• Diabetes Mellitus, Type 2 (blood)
• Double-Blind Method
• Drug Therapy, Combination
• Estrogens (administration & dosage, adverse effects, therapeutic use)
• Female
• Glucose Intolerance (blood)
• Hormone Replacement Therapy (adverse effects, methods)
• Humans
• Informed Consent
• Middle Aged
• Norethindrone (administration & dosage, analogs & derivatives)
• Norethindrone Acetate
• Postmenopause (blood)