NCT01905722

Brief Summary

The overarching goal of this program project grant is the development of technologies that lead to new methods for studying, detecting, and treating type 2 diabetes, and their integration with hypothesis-driven diabetes research projects. Project 4 of the grant, led by Dr. Craig Malloy at UTSW, will develop and apply new technology in MRI to test core hypotheses about the development of insulin resistance in people. The long-term goal is to develop technology to monitor metabolism in skeletal muscle, brain and the liver using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) in a 3 Tesla and 7 Tesla MRI scanners. These advanced imaging methods allow researchers to take pictures of the inside of the body and to measure metabolism as it occurs in the MRI scanner. Standard clinical MRI for medical diagnosis and treatment is performed in a 1 Tesla or 3 Tesla MRI scanner. A primary goal of the 7 Tesla research program is to develop a group of protocols for investigating specific metabolic pathways in adipose (fat) tissue, skeletal muscle and the liver. This study is being done to improve methods of imaging and measuring molecules in a 3 Tesla or 7 Tesla scanners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

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

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

December 10, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3.4 years

First QC Date

July 19, 2013

Last Update Submit

May 29, 2019

Conditions

Metabolism

Keywords

MRImetabolismhealthy7 Tesla

Outcome Measures

Primary Outcomes (1)

  • Identification of metabolic tracers for optimal data in future metabolic studies.

    The primary outcome measure will be the identification of metabolic tracers that will yield optimal data to apply to disease processes in future metabolic studies.

    90 minutes

Study Arms (2)

3 Tesla

OTHER

3 Tesla scanning with intravenous infusion of tracers

Other: 3 Tesla

7 Tesla

EXPERIMENTAL

7 Tesla scanning with intravenous infusion of tracers

Other: 7 Tesla

Interventions

3 TeslaOTHER

3 Tesla scanning with intravenous infusion of tracers

3 Tesla
7 TeslaOTHER

7 Tesla scanning with intravenous infusion of tracers

7 Tesla

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health (normal vital signs; no acute signs or symptoms of illness)
  • Able to give informed consent
  • Able to tolerate study procedures including insertion of an intravenous catheter and approximately 90 minutes in the MRI scanner
  • Aim 3 phase subjects will have BMI of 28 to 35 and a sedentary lifestyle; may be pre-diabetic or have undiagnosed type 2 diabetes

You may not qualify if:

  • Known diagnosed disease, including known heart rhythm disturbance, cancer or risk of seizure disorder or other disorder that could create risk to the subject
  • Pregnancy
  • Subjects with implanted metal that would compromise safety in MR use
  • Subjects not fluent in English will be excluded because the immediate ability to respond to instructions in the scanner is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (3)

  • Jones JG, Solomon MA, Cole SM, Sherry AD, Malloy CR. An integrated (2)H and (13)C NMR study of gluconeogenesis and TCA cycle flux in humans. Am J Physiol Endocrinol Metab. 2001 Oct;281(4):E848-56. doi: 10.1152/ajpendo.2001.281.4.E848.

    PMID: 11551863BACKGROUND

  • Jones JG, Carvalho RA, Franco B, Sherry AD, Malloy CR. Measurement of hepatic glucose output, krebs cycle, and gluconeogenic fluxes by NMR analysis of a single plasma glucose sample. Anal Biochem. 1998 Oct 1;263(1):39-45. doi: 10.1006/abio.1998.2796.

    PMID: 9750140BACKGROUND

  • Burgess SC, Weis B, Jones JG, Smith E, Merritt ME, Margolis D, Dean Sherry A, Malloy CR. Noninvasive evaluation of liver metabolism by 2H and 13C NMR isotopomer analysis of human urine. Anal Biochem. 2003 Jan 15;312(2):228-34. doi: 10.1016/s0003-2697(02)00465-7.

    PMID: 12531210BACKGROUND

Study Officials

  • Christopher Newgard, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Craig R. Malloy, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

December 10, 2013

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations

US(1)