To see if fenofibrate has any advantage over atorvastatin in effects on insulin sensitivity in volunteers with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus, insulin resistance; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN70518596
• Lead Sponsor: Belfast Health and Social Care Trust (UK)

Brief Summary

1. European Association for the Study of Diabetes, 2007 Black RN, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The PPARa agonist fenofibrate does not improve insulin sensitivity in type 2 diabetes in man; results of a randomised trial. Diabetologia 2007; 50(suppl 1): S320. 2. Diabtes UK, 2007 Black RNA, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The effect of PPAR alpha agonist fenofibrate on insulin sensitivity in man: a randomised controlled trial. Diabetic Medicine 2007; 24(suppl 1): 44. 2014 results in https://pubmed.ncbi.nlm.nih.gov/24560135/ (added 12/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-01-25
• Study Start: 2008-05-15
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

1. Males and post-menopausal females
2. Aged 35-70 years old
3. Type 2 diabetes mellitus, clinically well
4. On diet or oral anti-diabetic therapy
5. Fasting total triglyceride <4.5 mmol/L

Exclusion Criteria

1. Age <35 or >70 years
2. Total fasting triglycerides pre-treatment or after withdrawal of previous therapy >= 4.5mmol/L
3. Total cholesterol >6.5 mmol/L
4. Excess alcohol consumption
5. Ischaemic heart, peripheral vascular or cerebrovascular disease
6. Hepatic disease
7. Epilepsy
8. Body mass index >35 kg/m^2
9. Pre-menopausal females
10. HbA1c >8%
11. Current insulin or thiazolidinedione therapy within 6 months
12. Significant renal impairment or overt proteinuria (serum creatinine >150 µmol/L, estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula <50 mL/minute, urine spot albumin >200 mg/L, albumin-creatinine ratio >20 mg/mmol or 24-hour urine protein >300 mg)
13. Uncontrolled hypertension (>140/80 mmHg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose infusion rate required to maintain isoglycaemia in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute. This was assessed within three days of the end of each treatment period.

Secondary Outcome Measures

Name	Time	Method
<br> The following were assessed within three days of the end of each treatment period:<br> 1. Isotopically-determined total body glucose disposal rate and suppression of endogenous glucose production in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute<br> 2. Serum total, low-density and high density cholesterol and fasting total triglyceride<br>