DiabetesNCT00222781
Multi-Tracer PET Quantitation of Skeletal Muscle Insulin Resistance in Type 2 Diabetes Mellitus
An observational study of Diabetes and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this research is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone made by your body to control the blood sugar level. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- We will recruit eight normal weight (BMI 19 to 25 kg/m2), and eight overweight or obese (BMI 27 to 38 kg/m2), non-diabetic, healthy volunteers, who are between the ages of 30 to 55 years old. For scientific reasons it is crucial that the groups are age matched. Limiting the age range to a period of 25 years will help achieve this goal. Volunteers for these two groups must have a fasting glucose < 110 mg/dl; HbA1c < 6.0%; Hct > 34; ALT < 60; AST < 60; Alk phos < 150; sTSH < 8; Trig < 300; Chol < 250; systolic BP < 150; diastolic BP < 95; and be in good health. A medical history and physical exam will be conducted by a nurse practitioner or a medical doctor.
- We will also recruit eight volunteers with type 2 DM; as the large majority of this patient population is overweight or obese, inclusion criteria will include BMI 27 to 38 kg/m2, and otherwise age- and gender-matched to the non-diabetic volunteers. At screening, HbA1c must be less than 8.5%. For scientific purposes we would like to study the volunteers with type 2 DM without the confounding effects of anti-diabetic medications, therefore, we propose to restrict recruitment to those who are either treated by diet and exercise alone, or to those who are on oral agents in the sulfonylurea class, metformin, or acarbose.
Who cannot join
- We will exclude volunteers taking thiazolidinediones as the washout period for this class is uncertain, and exclude those taking insulin as withdrawal likely would cause unacceptable levels of hyperglycemia.
- Research volunteers with type 2 DM who are enrolled in the study and who are receiving oral diabetic agents (sulfonylureas, metformin or acarbose), will be instructed to withhold these medications for five days preceding both PET studies.
- Previous difficulty with lidocaine (xylocaine) will be an exclusion. To be eligible for these studies, volunteers must be free of clinical evidence of cardiac, renal, hepatic, and vascular disease, or other major medical problems that would endanger the volunteers or compromise the scientific validity of the studies. Subjects with a history of myocardial infarction, proteinuria (defined as 1+ protein), alcohol or drug abuse, malignancy or neuromuscular disease will be excluded. Subjects who have gained or lost more than 3 kg during the past 3 months will be excluded. Because of the PET, MR, and DEXA scanning, all premenopausal women must have a negative pregnancy test within 24 hours prior to these procedures. To avoid radiation exposure of the infant, women who are currently breastfeeding will not be permitted to participate in this research study. Subjects will be excluded if they have a contraindication to MRI such as surgical or vascular implants, pregnancy, pacemaker, or claustrophobia. In subjects with a questionable history of metallic fragments, an X-ray of the suspected area of the body will be performed to rule such out.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Three-Tracer PET Quantitation of Insulin Action in Muscle
The purpose of this research is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone made by your body to control the blood sugar level. "Resistance' to insulin could cause poor blood glucose control (blood sugar levels that are higher than normal). We want to use this new method to image (look at) the following three things: 1) how insulin affects blood flow in skeletal muscle 2) how insulin affects glucose (sugar) transport (movement) into muscle, and 3) how insulin affects glucose metabolism (breakdown) in skeletal muscle of healthy individuals.
PET imaging is a relatively non-invasive way to obtain a "metabolic picture" of body organs and has been used successfully to study brain, heart and more recently skeletal muscle. In this research study, we will use PET, with three radioactive tracers (markers), to study skeletal muscle glucose transport in individuals with type 2 diabetes mellitus (type 2 DM) and in non-diabetic individuals who are either normal weight or overweight/obese
Read the detailed description
The goal of this proposal is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance (IR) in research volunteers with type 2 diabetes mellitus (type 2 DM) and in comparison to age and gender-matched, normal weight non-diabetic volunteers, and in comparison to age, gender, and weight-matched overweight or obese non-diabetic volunteers. We will use the three tracers to obtain data on the respective insulin actions upon tissue perfusion, glucose transport and glucose phosphorylation in order to test the hypothesis that insulin resistance (IR) in type 2 DM is caused by an aggregation of impairments at these steps, thus challenging the prevalent concept that IR derives from a solitary impairment in trans-membrane transport.
Proximal steps of glucose transport and phosphorylation are considered to contribute strongly to the pathogenesis of IR in obesity and type 2 DM (1-5). These scientific considerations might have potential therapeutic implications. The overall goal of this project is to provide clarity in separating the respective roles of these proximal steps of glucose metabolism. Glucose transport will be assessed using 11C-3-O-methyl glucose (half-life ~ 20 min; also referred to as 3-0-MG), an analog that is transported but not phosphorylated. 18F-2-deoxy-2-fluoro-glucose (half-life ~ 109 min; also referred to as FDG), will be used to assess glucose transport and glucose phosphorylation. The third tracer that will be used, 15O-H2O, will provide information on tissue perfusion. The challenge with the use of FDG to study insulin action in muscle has been to derive data on two biochemical steps from the tissue activity pattern of a single tracer; this has placed a higher reliance upon the modeling of the data. However, in this project, because of the use of three tracers and the differences in the metabolism of the two glucose analogs, we will be able to address with clear resolution the respective roles of transport and phosphorylation in the pathogenesis of IR in obesity and type 2 DM.
- Keywords
- Skeletal muscle, Triple-tracer PET imaging
- Medical subject headings
- Diabetes Mellitus, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare triple tracer PET imaging of skeletal muscle in lean, obese and T2DM
Secondary outcomes (1)
Mathematical modeling of PET data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- David E Kelley, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222781
- Sponsor's protocol ID
- 0311010
- Other IDs
- R01DK060555
- Status last verified
- Dec 2007
- First submitted
- 19 Sep 2005
- Last updated
- 19 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Tracer PET Quantitation of Insulin Action in Muscle
- ClinicalTrials.gov ID
- NCT00222781
- Acronym / sponsor ID
- 0311010
- Keywords
- Skeletal muscle, Triple-tracer PET imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2004
- Study completion
- Dec 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone made by your body to control the blood sugar level. "Resistance' to insulin could cause poor blood glucose control (blood sugar levels that are higher than normal). We want to use this new method to image (look at) the following three things: 1) how insulin affects blood flow in skeletal muscle 2) how insulin affects glucose (sugar) transport (movement) into muscle, and 3) how insulin affects glucose metabolism (breakdown) in skeletal muscle of healthy individuals.
PET imaging is a relatively non-invasive way to obtain a "metabolic picture" of body organs and has been used successfully to study brain, heart and more recently skeletal muscle. In this research study, we will use PET, with three radioactive tracers (markers), to study skeletal muscle glucose transport in individuals with type 2 diabetes mellitus (type 2 DM) and in non-diabetic individuals who are either normal weight or overweight/obese
Detailed description
The goal of this proposal is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance (IR) in research volunteers with type 2 diabetes mellitus (type 2 DM) and in comparison to age and gender-matched, normal weight non-diabetic volunteers, and in comparison to age, gender, and weight-matched overweight or obese non-diabetic volunteers. We will use the three tracers to obtain data on the respective insulin actions upon tissue perfusion, glucose transport and glucose phosphorylation in order to test the hypothesis that insulin resistance (IR) in type 2 DM is caused by an aggregation of impairments at these steps, thus challenging the prevalent concept that IR derives from a solitary impairment in trans-membrane transport.
Proximal steps of glucose transport and phosphorylation are considered to contribute strongly to the pathogenesis of IR in obesity and type 2 DM (1-5). These scientific considerations might have potential therapeutic implications. The overall goal of this project is to provide clarity in separating the respective roles of these proximal steps of glucose metabolism. Glucose transport will be assessed using 11C-3-O-methyl glucose (half-life ~ 20 min; also referred to as 3-0-MG), an analog that is transported but not phosphorylated. 18F-2-deoxy-2-fluoro-glucose (half-life ~ 109 min; also referred to as FDG), will be used to assess glucose transport and glucose phosphorylation. The third tracer that will be used, 15O-H2O, will provide information on tissue perfusion. The challenge with the use of FDG to study insulin action in muscle has been to derive data on two biochemical steps from the tissue activity pattern of a single tracer; this has placed a higher reliance upon the modeling of the data. However, in this project, because of the use of three tracers and the differences in the metabolism of the two glucose analogs, we will be able to address with clear resolution the respective roles of transport and phosphorylation in the pathogenesis of IR in obesity and type 2 DM.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- We will recruit eight normal weight (BMI 19 to 25 kg/m2), and eight overweight or obese (BMI 27 to 38 kg/m2), non-diabetic, healthy volunteers, who are between the ages of 30 to 55 years old. For scientific reasons it is crucial that the groups are age matched. Limiting the age range to a period of 25 years will help achieve this goal. Volunteers for these two groups must have a fasting glucose < 110 mg/dl; HbA1c < 6.0%; Hct > 34; ALT < 60; AST < 60; Alk phos < 150; sTSH < 8; Trig < 300; Chol < 250; systolic BP < 150; diastolic BP < 95; and be in good health. A medical history and physical exam will be conducted by a nurse practitioner or a medical doctor.
- We will also recruit eight volunteers with type 2 DM; as the large majority of this patient population is overweight or obese, inclusion criteria will include BMI 27 to 38 kg/m2, and otherwise age- and gender-matched to the non-diabetic volunteers. At screening, HbA1c must be less than 8.5%. For scientific purposes we would like to study the volunteers with type 2 DM without the confounding effects of anti-diabetic medications, therefore, we propose to restrict recruitment to those who are either treated by diet and exercise alone, or to those who are on oral agents in the sulfonylurea class, metformin, or acarbose.
Key exclusion criteria (3 listed)
- We will exclude volunteers taking thiazolidinediones as the washout period for this class is uncertain, and exclude those taking insulin as withdrawal likely would cause unacceptable levels of hyperglycemia.
- Research volunteers with type 2 DM who are enrolled in the study and who are receiving oral diabetic agents (sulfonylureas, metformin or acarbose), will be instructed to withhold these medications for five days preceding both PET studies.
- Previous difficulty with lidocaine (xylocaine) will be an exclusion. To be eligible for these studies, volunteers must be free of clinical evidence of cardiac, renal, hepatic, and vascular disease, or other major medical problems that would endanger the volunteers or compromise the scientific validity of the studies. Subjects with a history of myocardial infarction, proteinuria (defined as 1+ protein), alcohol or drug abuse, malignancy or neuromuscular disease will be excluded. Subjects who have gained or lost more than 3 kg during the past 3 months will be excluded. Because of the PET, MR, and DEXA scanning, all premenopausal women must have a negative pregnancy test within 24 hours prior to these procedures. To avoid radiation exposure of the infant, women who are currently breastfeeding will not be permitted to participate in this research study. Subjects will be excluded if they have a contraindication to MRI such as surgical or vascular implants, pregnancy, pacemaker, or claustrophobia. In subjects with a questionable history of metallic fragments, an X-ray of the suspected area of the body will be performed to rule such out.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare triple tracer PET imaging of skeletal muscle in lean, obese and T2DM
1 secondary outcome
Mathematical modeling of PET data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Kelley, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare triple tracer PET imaging of skeletal muscle in lean, obese and T2DM. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.