Plant Stanols and Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stanol ester spread<br>Vegetable oil based margarine with stanol ester enrichment | Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment<br>* 3 g plant stanols/ day<br>|
| Placebo Comparator: control spread<br>Vegetable oil based margarine without stanol ester enrichment | Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment<br>* 3 g plant stanols/ day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum lipids |  | Week 0 | 
| serum lipids |  | Week 3 | 
| serum lipids |  | Week 4 | 
| squalene |  | Week 0 | 
| squalene |  | Week 3 | 
| squalene |  | Week 4 | 
| non-cholesterol sterols |  | Week 0 | 
| non-cholesterol sterols |  | Week 3 | 
| non-cholesterol sterols |  | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant stanols, type 1 diabetes, sterol metabolism, cholesterol