ObesityPhase 1NCT01860911
Plasma Triglyceride Extraction by The Muscle
A Phase 1 study testing Insulin and NG-monomethyl-L-arginine in people with Obesity and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial summary
Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Insulin and NG-monomethyl-L-arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Aug 2016
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI): < 25 kg/m2 or > 30 kg/m2;
- Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.
Who cannot join
- Medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil)
- Acute illness
- Uncontrolled metabolic disease, including liver or renal disease
- Atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts
- Cardiac pacemaker or other medical device implanted in the body
- Pulmonary hypertension or other unstable cardiopulmonary conditions
Show all 13Show fewer
- ECG documented abnormalities or valvular disease
- Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values)
- History of hypertension or elevated blood pressure (systolic, >140 mmHg or a diastolic, >95 mmHg)
- History of hyperlipidemia or plasma triglyceride concentration >200 mg/dl
- Diagnosed diabetes, or 2-h plasma glucose >200 mg/dl during an oral glucose tolerance test
- Current participation in a weight-loss regimen, including extreme dietary practices
- Use of anabolic steroids or corticosteroids (within 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance
Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Insulin, NG-monomethyl-L-arginine
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
NG-monomethyl-L-arginineDrug
| Study group | Role | What they receive |
|---|---|---|
| Insulin-Sensitive | Experimental | One group consists of insulin sensitive volunteers. Receives: Drug: Insulin; Drug: NG-monomethyl-L-arginine |
| Insulin-Resistant | Experimental | One group consists of insulin resistant volunteers. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride extraction across the forearm
Measured: Measured during a 7-hour infusion study
Secondary outcomes (1)
Muscle microvascular blood volume
Measured: Selected 15-minute periods during the 7 hour infusion study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Lori R. Roust, Mayo Clinic
- Investigators
- Lori Roust, MD, Principal investigator, Mayo ClinicChristos S Katsanos, PhD, Principal investigator, Arizona State University/Mayo Clinic Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860911
- Sponsor's protocol ID
- 12-005173
- Status last verified
- Oct 2021
- First submitted
- 21 May 2013
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance
- ClinicalTrials.gov ID
- NCT01860911
- Acronym / sponsor ID
- 12-005173
- Conditions
- Obesity, Insulin Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Apr 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 23 May 2013 (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.
Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin-Sensitive | Experimental | Drug: Insulin, Drug: NG-monomethyl-L-arginineOne group consists of insulin sensitive volunteers. |
| Insulin-Resistant | Experimental | Drug: InsulinOne group consists of insulin resistant volunteers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI): < 25 kg/m2 or > 30 kg/m2;
- Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.
Key exclusion criteria (13 listed)
- Medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil)
- Acute illness
- Uncontrolled metabolic disease, including liver or renal disease
- Atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts
- Cardiac pacemaker or other medical device implanted in the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin | Drug | Insulin-Resistant, Insulin-Sensitive |
| NG-monomethyl-L-arginine | Drug | Insulin-Sensitive |
Primary outcome
Triglyceride extraction across the forearm
Time frame: Measured during a 7-hour infusion study
1 secondary outcome
Muscle microvascular blood volume
Time frame: Selected 15-minute periods during the 7 hour infusion study
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 8 Oct 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Lori Roust, MD principal investigator
Mayo Clinic
Christos S Katsanos, PhD principal investigator
Arizona State University/Mayo Clinic Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin and NG-monomethyl-L-arginine in people with Obesity and Insulin Resistance, run by Mayo Clinic 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 13 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 8 Oct 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Triglyceride extraction across the forearm (time frame: Measured during a 7-hour infusion study). 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 8 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.