A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563834
• Other study ID #: 10100002643
• Secondary ID: R21DK071142
• Status: Completed
• Phase: N/A
• First received: September 29, 2015
• Last updated: August 30, 2016
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• thiapalmitate tracer
Radiolabeled tracer infusion; occurs in all treatment arms
• Saline
Saline infusion for control
• Insulin
Insulin infusion for insulin/glucose clamp procedure

Locations

Country	Name	City	State
United States	Indiana University Hospital GCRC	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Fatty Acid Uptake Rate	PET measure of fatty acid uptake rate	4 Hours	No
Secondary	Myocardial Oxidation Rate	PET measure of total oxidation rate	4 Hours	No
Secondary	Myocardial Perfusion Rate	PET measure of total myocardial perfusion (blood flow)	4 Hours	No