NCT01205308

Plant Stanols and Type 1 Diabetes

Effects of Plant Stanol Esters on Serum Lipids, Precursors of Cholesterol Synthesis and Plant Sterols in Type 1 Diabetics on Stabile Statin Drug Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Marjukka Kolehmainen · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. The aim of this study is to investigate the effects of plant stanol esters on serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as cholesterol metabolism in T1 diabetics on statin use. The study will give new information about how addition of plant stanol esters on statin use improve hypolipidemic effects in type 1 diabetes.

Detailed description

In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. Thus, theoretically, the best way to reduce serum cholesterol concentrations is to reduce cholesterol absorption. However, statins are recommended to T1 diabetics at the same LDL cholesterol levels as for type 2 diabetics to reduce risk to CAD. The aim of this study is to investigate the effects of plant stanol esters on serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as cholesterol metabolism in T1 diabetics on statin use. Altogether, twenty-four T1 diabetics (HbA1c \<9%) on stabile statin use will be recruited to the study from an announcement in the local newspaper and from Kuopio University Hospital and Harjula Hospital. The study is carried out with a randomized, double-blind and parallel design. The intervention group (n=12) consumes spread enriched with plant stanol esters (3 g/d stanols) and the control group (n=12) the same spread containing no added stanols for 4 weeks. The fasting blood samples are taken at weeks 0, 3 and 4. From blood samples concentrations of serum lipids, squalene and non-cholesterol sterols will be analyzed.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vegetable oil based margarine with plant stanol ester enrichment	3 g plant stanols/ day

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2010-09-20
• Last updated: 2012-04-17

Locations

1 site across 1 country: Finland