| Methods |
DURATION OF INTERVENTION:
26 weeks
DURATION OF FOLLOW‐UP:
26 weeks
RUN‐IN PERIOD:
4‐weeks with written diet instructions
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
patients with newly diagnosed or diet‐treated type 2 diabetes
INCLUSION CRITERIA:
patients with type 2 diabetes, as defined by the WHO criteria and no diabetes complications
EXCLUSION CRITERIA:
fasting plasma glucose value < 6.1 mmol/l or > 11.0 mmol/L after the run‐in period; patients with cardiovascular disease, blood pressure > 160/100 mm Hg, previous or present abnormal hepatic or renal function, antidiabetic medication, anemia, or oral corticosteroid treatment
DIAGNOSTIC CRITERIA:
WHO 1998
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
| Interventions |
NUMBER OF STUDY CENTRES:
not stated (1)
COUNTRY/ LOCATION:
Finland
SETTING:
the patients were recruited by advertisement and among clients of the occupational health service in Turku, Finland
INTERVENTION (DOSE/DAY):
rosiglitazone 8 mg/day (4 mg b.i.d.)
CONTROL (DOSE/DAY):
C1: metformin 2 g (1g b.i.d.)
C2: placebo
TREATMENT BEFORE STUDY:
none or diet only
TITRATION PERIOD:
rosiglitazone (2 mg b.i.d. for 2 weeks, thereafter 4 mg b.i.d.), metformin (500 mg b.i.d. for 2 weeks, thereafter 1 g b.i.d.), or placebo |
| Outcomes |
PRIMARY OUTCOMES:
not stated (insulin‐ and exercise‐stimulated skeletal muscle glucose uptake, measured by means of positron emission tomography (PET) during euglycemic‐hyperinsulinemic
clamp and one‐legged exercise)
SECONDARY OUTCOMES:
(not stated)
FPG, insulin, HbA1c, body weight, blood pressure |
| Notes |
AIM OF STUDY:
to compare the effects of treatment with rosiglitazone and metformin on insulin‐ and exercise‐stimulated glucose uptake and perfusion in skeletal muscle tissue in patients with type 2 diabetes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
