Type 2 Diabetes Mellitus
Conditions
Brief summary
Studies of myocardial fuel selection using a novel palmitate-based PET probe
Detailed 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.
Interventions
DRUGthiapalmitate tracer
Radiolabeled tracer infusion; occurs in all treatment arms
DRUGSaline
Saline infusion for control
DRUGInsulin
Insulin infusion for insulin/glucose clamp procedure
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Fatty Acid Uptake Rate | 4 Hours | PET measure of fatty acid uptake rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Oxidation Rate | 4 Hours | PET measure of total oxidation rate |
| Myocardial Perfusion Rate | 4 Hours | PET measure of total myocardial perfusion (blood flow) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lean Controls Lean non-diabetic control participants, taking no regular medications. | 10 |
| Type 2 Diabetes Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Lean Controls | Type 2 Diabetes | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Continuous | 34.1 years STANDARD_DEVIATION 9 | 40.4 years STANDARD_DEVIATION 9.2 | 36.9 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Myocardial Fatty Acid Uptake Rate
PET measure of fatty acid uptake rate
Time frame: 4 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean Control - Saline | Myocardial Fatty Acid Uptake Rate | 18.492 umol/min/100g | Standard Error 3.942 |
| Lean Control - Insulin Clamp | Myocardial Fatty Acid Uptake Rate | 2.123 umol/min/100g | Standard Error 1.087 |
| Type 2 DM - Saline | Myocardial Fatty Acid Uptake Rate | 36.005 umol/min/100g | Standard Error 4.408 |
| Type 2 DM - Insulin Clamp | Myocardial Fatty Acid Uptake Rate | 7.8 umol/min/100g | Standard Error 1.215 |
Secondary
Myocardial Oxidation Rate
PET measure of total oxidation rate
Time frame: 4 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean Control - Saline | Myocardial Oxidation Rate | 15.006 ml/min/100g | Standard Error 0.951 |
| Lean Control - Insulin Clamp | Myocardial Oxidation Rate | 19.847 ml/min/100g | Standard Error 1.773 |
| Type 2 DM - Saline | Myocardial Oxidation Rate | 17.381 ml/min/100g | Standard Error 1.064 |
| Type 2 DM - Insulin Clamp | Myocardial Oxidation Rate | 22.940 ml/min/100g | Standard Error 2.288 |
Secondary
Myocardial Perfusion Rate
PET measure of total myocardial perfusion (blood flow)
Time frame: 4 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean Control - Saline | Myocardial Perfusion Rate | 39.3 ml/min/100g | Standard Error 2.1 |
| Lean Control - Insulin Clamp | Myocardial Perfusion Rate | 46.5 ml/min/100g | Standard Error 3.3 |
| Type 2 DM - Saline | Myocardial Perfusion Rate | 44.2 ml/min/100g | Standard Error 2.3 |
| Type 2 DM - Insulin Clamp | Myocardial Perfusion Rate | 49.4 ml/min/100g | Standard Error 4.2 |