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

Not Applicable

Completed

• Conditions: Type two diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN58905233
• Lead Sponsor: Hospital Sant Pau (Spain)

Brief Summary

2003 Results article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=12843167

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2001-05-01
• Study Start: 2007-04-24
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect on components of diabetic dyslipidaemia (especially apoB and LDL size).

Secondary Outcome Measures

Name	Time	Method
Concentrations of inflammatory markers.