title: 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).
  
  
  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).
  
  
  CONCLUSIONS
  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.affiliation: Service de Pharmacologie Clinique, EA643, Lyon University Hospital, Faculté RTH Laennec, BP 8071, 69376 Cedex 08, Lyon, France. catherine.cornu@upcl.univ-lyon1.fr
authors.forename: C
authors.initials: C
authors.lastname: Cornu
authors.forename: C
authors.initials: C
authors.lastname: Mercier
authors.forename: P
authors.initials: P
authors.lastname: Ffrench
authors.forename: C
authors.initials: C
authors.lastname: Bully
authors.forename: M
authors.initials: M
authors.lastname: Pugeat
authors.forename: P
authors.initials: P
authors.lastname: Cousin
authors.forename: J P
authors.initials: JP
authors.lastname: Riou
authors.forename: L
authors.initials: L
authors.lastname: Bajart
authors.forename: J
authors.initials: J
authors.lastname: Orgiazzi
authors.forename: C
authors.initials: C
authors.lastname: Pommet-Nicot
authors.forename: P
authors.initials: P
authors.lastname: Darsy
authors.forename: J P
authors.initials: JP
authors.lastname: Boissel
authors.forename: F
authors.initials: F
authors.lastname: Berthezène
mesh_terms: D015415:Biomarkers / Q000097:blood; D002715:Chlormadinone Acetate / Q000008:administration & dosage; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D018149:Glucose Intolerance / Q000097:blood*; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077563:Norethindrone Acetate; D017698:Postmenopause / Q000097:blood
chemical_list: D015415:Biomarkers; D004967:Estrogens; D002715:Chlormadinone Acetate; D000077563:Norethindrone Acetate; D009640:Norethindrone