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Plant Stanols and Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Kuopio University Hospital
Raisio Plc.
Information provided by (Responsible Party):
Marjukka Kolehmainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01205308
First received: September 13, 2010
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment

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

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • serum lipids [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • serum lipids [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • serum lipids [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • squalene [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • squalene [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • squalene [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • non-cholesterol sterols [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • non-cholesterol sterols [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • non-cholesterol sterols [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stanol ester spread
Vegetable oil based margarine with stanol ester enrichment
Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day
Placebo Comparator: control spread
Vegetable oil based margarine without stanol ester enrichment
Dietary Supplement: Vegetable oil based margarine with plant stanol ester enrichment
3 g plant stanols/ day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205308

Locations
Finland
University of Eastern Finland
Kuopio, Finland, FIN-70211
Sponsors and Collaborators
Marjukka Kolehmainen
Kuopio University Hospital
Raisio Plc.
Investigators
Study Director: Helena Gylling, Professor University of Eastern Finland
Principal Investigator: Maarit Hallikainen, PhD University of Eastern Finland
  More Information

No publications provided

Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01205308     History of Changes
Other Study ID Numbers: 125/2009
Study First Received: September 13, 2010
Last Updated: April 16, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
Plant stanols
type 1 diabetes
sterol metabolism
cholesterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014