Trial Outcomes & Findings for A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism (NCT NCT02563834)
NCT ID: NCT02563834
Last Updated: 2016-08-31
Results Overview
PET measure of fatty acid uptake rate
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
4 Hours
Results posted on
2016-08-31
Participant Flow
Participant milestones
| Measure |
Lean Control
Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control
|
Type 2 DM
Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
|---|---|---|
|
Control (Saline) Infusion (*Day 1)
STARTED
|
10
|
8
|
|
Control (Saline) Infusion (*Day 1)
COMPLETED
|
10
|
8
|
|
Control (Saline) Infusion (*Day 1)
NOT COMPLETED
|
0
|
0
|
|
Insulin Infusion (*Day 2)
STARTED
|
10
|
8
|
|
Insulin Infusion (*Day 2)
COMPLETED
|
10
|
8
|
|
Insulin Infusion (*Day 2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Baseline characteristics by cohort
| Measure |
Lean Controls
n=10 Participants
Lean non-diabetic control participants, taking no regular medications.
|
Type 2 Diabetes
n=8 Participants
Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 HoursPET measure of fatty acid uptake rate
Outcome measures
| Measure |
Lean Control - Saline
n=10 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control
|
Lean Control - Insulin Clamp
n=10 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure
|
Type 2 DM - Saline
n=8 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
Type 2 DM - Insulin Clamp
n=8 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
|---|---|---|---|---|
|
Myocardial Fatty Acid Uptake Rate
|
18.492 umol/min/100g
Standard Error 3.942
|
2.123 umol/min/100g
Standard Error 1.087
|
36.005 umol/min/100g
Standard Error 4.408
|
7.8 umol/min/100g
Standard Error 1.215
|
SECONDARY outcome
Timeframe: 4 HoursPET measure of total oxidation rate
Outcome measures
| Measure |
Lean Control - Saline
n=10 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control
|
Lean Control - Insulin Clamp
n=10 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure
|
Type 2 DM - Saline
n=8 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
Type 2 DM - Insulin Clamp
n=8 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
|---|---|---|---|---|
|
Myocardial Oxidation Rate
|
15.006 ml/min/100g
Standard Error 0.951
|
19.847 ml/min/100g
Standard Error 1.773
|
17.381 ml/min/100g
Standard Error 1.064
|
22.940 ml/min/100g
Standard Error 2.288
|
SECONDARY outcome
Timeframe: 4 HoursPET measure of total myocardial perfusion (blood flow)
Outcome measures
| Measure |
Lean Control - Saline
n=10 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Saline: Saline infusion for control
|
Lean Control - Insulin Clamp
n=10 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
Insulin: Insulin infusion for insulin/glucose clamp procedure
|
Type 2 DM - Saline
n=8 Participants
Studies will be performed on a separate 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).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
Type 2 DM - Insulin Clamp
n=8 Participants
Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms
|
|---|---|---|---|---|
|
Myocardial Perfusion Rate
|
39.3 ml/min/100g
Standard Error 2.1
|
46.5 ml/min/100g
Standard Error 3.3
|
44.2 ml/min/100g
Standard Error 2.3
|
49.4 ml/min/100g
Standard Error 4.2
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Clamp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place