NCT02563834

Brief Summary

Studies of myocardial fuel selection using a novel palmitate-based PET probe

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable type-2-diabetes-mellitus

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

January 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

September 29, 2015

Results QC Date

February 29, 2016

Last Update Submit

August 30, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Myocardial Fatty Acid Uptake Rate

    PET measure of fatty acid uptake rate

    4 Hours

Secondary Outcomes (2)

  • Myocardial Oxidation Rate

    4 Hours

  • Myocardial Perfusion Rate

    4 Hours

Study Arms (2)

Saline

EXPERIMENTAL

Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

Drug: thiapalmitate tracerDrug: Saline

Insulin Clamp

EXPERIMENTAL

Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

Drug: thiapalmitate tracerDrug: Insulin

Interventions

thiapalmitate tracerDRUG

Radiolabeled tracer infusion; occurs in all treatment arms

Also known as: 16- 18-F-fluoro-4-thiapalmitate
Insulin ClampSaline
SalineDRUG

Saline infusion for control

Saline
InsulinDRUG

Insulin infusion for insulin/glucose clamp procedure

Insulin Clamp

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Lean:
  • BMI\<25 kg/m2
  • normal glucose tolerance by 75g oral glucose tolerance test
  • Type 2 diabetes mellitus:
  • BMI \>25 kg/m2
  • previously diagnosed type 2 diabetes mellitus
  • on oral and/or injected insulin treatment.

You may not qualify if:

  • Lean:
  • \*Use of any chronic medications
  • Type 2 diabetes mellitus
  • known microvascular disease
  • known coronary or other macro vascular disease
  • use of PPARgamma class antidiabetic agents within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital GCRC

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.

    PMID: 26732686RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium ChlorideInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Kieren J Mather
Organization
Indiana University
kmather@iu.edu
317-278-7826

Study Officials

  • Kieren J Mather, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 31, 2016

Results First Posted

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)