NCT01098994

Brief Summary

The purpose of the study is to determine whether the function of the good cholesterol (HDL cholesterol) as well as its subfractions (via NMR spectroscopy) is altered among people with type 1 diabetes and a variation in the Haptoglobin gene and to evaluate whether vitamin E supplements may improve this function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 3, 2014

Status Verified

June 1, 2014

Enrollment Period

3.8 years

First QC Date

February 24, 2010

Last Update Submit

June 2, 2014

Conditions

Type 1 DiabetesHeart Disease

Keywords

Type 1 diabetesHaptoglobin genotypeHDL functionHeart diseaseFeasibility of clinical trial

Outcome Measures

Primary Outcomes (1)

  • Demonstrate the presence of HDL dysfunction among individuals with the Haptoglobin 2/1 and 2/2 compared to those with the Hp 1/1 phenotype and improvement in HDL dysfunction with natural d-α-tocopherol supplementation

    HDL-associated lipid peroxides, HDL function (based on its ability to promote cholesterol efflux from macrophages), HDL antioxidant and anti-inflammatory activities; NMR lipoprotein subfractions will be assessed

    6 months

Secondary Outcomes (2)

  • Feasibility of recruitment of individuals with type 1 diabetes for a randomized clinical trial

    1 year

  • Assessment of adherence to the clinical trial study protocol in a random sample of individuals with type 1 diabetes recruited from the ACR and CHP/EDC Diabetes Registries

    6 months

Study Arms (3)

Haptoglobin 1/1

OTHER

Individuals with type 1 diabetes and the Haptoglobin 1/1 phenotype

Dietary Supplement: Vitamin EOther: Dummy pills

Haptoglobin 2/1

OTHER

Individuals with type 1 diabetes and the Haptoglobin 2/1 phenotype

Dietary Supplement: Vitamin EOther: Dummy pills

Haptoglobin 2/2

OTHER

Individuals with type 1 diabetes and the Haptoglobin 2/2 phenotype

Dietary Supplement: Vitamin EOther: Dummy pills

Interventions

Vitamin EDIETARY_SUPPLEMENT

Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks

Also known as: Natural d-alpha tocopherol acetate
Haptoglobin 1/1Haptoglobin 2/1Haptoglobin 2/2
Dummy pillsOTHER

Daily placebo administration for 8 weeks

Also known as: Placebo, inactive pills
Haptoglobin 1/1Haptoglobin 2/1Haptoglobin 2/2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with type 1 diabetes residing in the Pittsburgh, PA area (members of the Allegheny Count or Children's Hospital of Pittsburgh/Epidemiology of Diabetes Complications Registries)
  • years old or older
  • with diabetes duration greater than 10 years or less than 10 years but with a history of heart disease

You may not qualify if:

  • Allergy to vitamin E
  • Stroke, MI within the past 6 months
  • Unwillingness/inability to limit antioxidant supplement use to study-provided supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Diabetes and Lipid Research Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Heart Diseases

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tina Costacou, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Epidemiology

Study Record Dates

First Submitted

February 24, 2010

First Posted

April 6, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 3, 2014

Record last verified: 2014-06

Locations

US(1)