Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01205308
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2010-09-13
Brief Title:
Plant Stanols and Type 1 Diabetes
Sponsor:
Marjukka Kolehmainen
Organization:
University of Eastern Finland
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n12 consumes spread enriched with plant stanol esters 3 gd stanols and the control group n12 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
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 n12 consumes spread enriched with plant stanol esters 3 gd stanols and the control group n12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None