Plant Stanols and Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment

• Registration Number: NCT01205308
• Lead Sponsor: Marjukka Kolehmainen

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Primary Completion: 2010-10
• Study Completion: 2011-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• type 1 diabetes, stabile statin drug use, HbA1c <9%

Exclusion Criteria

• liver, kidney and thyroid dysfunction, severe diabetic proteinuria, gastroparesis, unstable CAD, unstable inflammatory gastrointestinal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stanol ester spread	Vegetable oil based margarine with plant stanol ester enrichment	Vegetable oil based margarine with stanol ester enrichment
control spread	Vegetable oil based margarine with plant stanol ester enrichment	Vegetable oil based margarine without stanol ester enrichment

Primary Outcome Measures

Name	Time	Method
serum lipids	Week 4
squalene	Week 4
non-cholesterol sterols	Week 4

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, Finland