Plant Stanols and Type 1 Diabetes

Marjukka Kolehmainen

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01205308

125/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 2 patient groups, including a placebo group

Stanol ester spread

Active Comparator group

Description:

Vegetable oil based margarine with stanol ester enrichment

Treatment:

Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment

control spread

Placebo Comparator group

Description:

Vegetable oil based margarine without stanol ester enrichment

Treatment:

Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment