Plant Stanols and Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205308
• Other study ID #: 125/2009
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: April 16, 2012
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Dietary Supplement:
• Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (3)

Lead Sponsor	Collaborator
Marjukka Kolehmainen	Kuopio University Hospital, Raisio Plc

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum lipids		Week 0	No
Primary	serum lipids		Week 3	No
Primary	serum lipids		Week 4	No
Primary	squalene		Week 0	No
Primary	squalene		Week 3	No
Primary	squalene		Week 4	No
Primary	non-cholesterol sterols		Week 0	No
Primary	non-cholesterol sterols		Week 3	No
Primary	non-cholesterol sterols		Week 4	No