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Apolipoprotein B and low density lipoprotein size in type two diabetes: effect of atorvastatin and gemfibrozil

Apolipoprotein B and low density lipoprotein size in type two diabetes: effect of atorvastatin and gemfibrozil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58905233
Enrollment
40
Registered
2007-04-24
Start date
1999-05-01
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type two diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

Patients will receive either: 1. Atorvastatin 10 - 20 mg/d 2. Gemfibrozil 900 - 1200 mg/d For 12 weeks, and then will receive: 3. 10 mg

Sponsors

Hospital Sant Pau (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women with type two diabetes, aged 35 to 75 years 2. No treatment known to interfere with lipid metabolism (nonselective B-blockers, high dose diuretics, systemic steroids, lipid-lowering drugs) in the month preceding inclusion in the study 3. Plasma Low Density Lipoprotein cholesterol (LDLc) greater than 100 mg/dl (2.6 mmol/litre), and triglycerides less than 400 mg/dl (4.51mmol/litre)

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. No reliable contraceptive method was used 3. Serum creatinine more than 1.7 mg/dl (150 umol/litre) 4. Hepatic dysfunction (transaminases greater than 1.5 times upper normal limit at inclusion) 5. Creatine kinase more than three times the upper normal limit 6. Acute or chronic disorders that might interfere with compliance

Design outcomes

Primary

MeasureTime frame
Effect on components of diabetic dyslipidaemia (especially apoB and LDL size).

Secondary

MeasureTime frame
Concentrations of inflammatory markers.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026