Plant Stanols and Type 1 Diabetes
Effects of Plant Stanol Esters on Serum Lipids, Precursors of Cholesterol Synthesis and Plant Sterols in Type 1 Diabetics on Stabile Statin Drug Use
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2010
CompletedFirst Posted
Study publicly available on registry
September 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 17, 2012
April 1, 2012
9 months
September 13, 2010
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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
Study Arms (2)
Stanol ester spread
ACTIVE COMPARATORVegetable oil based margarine with stanol ester enrichment
control spread
PLACEBO COMPARATORVegetable oil based margarine without stanol ester enrichment
Interventions
3 g plant stanols/ day
Eligibility Criteria
You may qualify if:
- type 1 diabetes, stabile statin drug use, HbA1c \<9%
You may not qualify if:
- liver, kidney and thyroid dysfunction, severe diabetic proteinuria, gastroparesis, unstable CAD, unstable inflammatory gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marjukka Kolehmainenlead
- Kuopio University Hospitalcollaborator
- Raisio Plccollaborator
Study Sites (1)
University of Eastern Finland
Kuopio, FIN-70211, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helena Gylling, Professor
University of Eastern Finland
- PRINCIPAL INVESTIGATOR
Maarit Hallikainen, PhD
University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior scientist
Study Record Dates
First Submitted
September 13, 2010
First Posted
September 20, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2010
Study Completion
March 1, 2011
Last Updated
April 17, 2012
Record last verified: 2012-04