Plant Stanols and Type 1 Diabetes | NCT01205308

Studies
Plant Stanols and Type 1 Diabetes

NCT01205308

Sponsor

Marjukka Kolehmainen

Status

Completed

Last Update Posted

Apr 17, 2012Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

Vegetable oil based margarine with plant stanol ester enrichment

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 17, 2010

First Posted Date

Sep 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marjukka Kolehmainen, Senior scientist, University of Eastern FinlandSponsor-Investigator

Lead Sponsor

Marjukka KolehmainenOTHER

Collaborators

Name	Class
Kuopio University Hospital	OTHER
Raisio Plc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stanol ester spread	Active Comparator	Vegetable oil based margarine with stanol ester enrichment	Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment
control spread	Placebo Comparator	Vegetable oil based margarine without stanol ester enrichment	Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vegetable oil based margarine with plant stanol ester enrichment	Dietary Supplement	3 g plant stanols/ day	Stanol ester spread control spread

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena Gylling, Professor	University of Eastern Finland	Study Director
Maarit Hallikainen, PhD	University of Eastern Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Eastern Finland		Kuopio		FIN-70211	Finland

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided