Overweight and ObesityNCT04759872
Insulin and Muscle Fat Metabolism
A study testing Hyperinsulinemic-euglycemic Clamp in people with Overweight and Obesity and Insulin Resistance, run by Oregon State University at 1 site in United States.
Trial summary
Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Resistance, Metabolic Disease
- What is being tested?
- Hyperinsulinemic-euglycemic Clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 7 Jun 2022
- Phase
- Interventional
- 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
- Age 30-55 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Who cannot join
- Regular exercise (>1 hour of planned exercise per week)
- Smoking, tobacco or nicotine use within the last 1-year
- Fasting glucose >126mg/dL
- Hypertension (systolic pressure >140 mmHg or diastolic pressure >90 mmHg)
- Chronic metabolic or cardiovascular health conditions
- Pregnant, nursing, irregular menses or post-menopausal
Show all 9Show fewer
- Lidocaine allergy
- Certain medications
- Diminished capacity for consent
Trial locations and contacts
1 site in 1 country.
About this study
Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.
- Conditions
- Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
- Being tested
- Hyperinsulinemic-euglycemic Clamp
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Metabolic Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic-euglycemic ClampOther
Participants will be administered a constant-rate insulin infusion (to induce mild hyperinsulinemia), with an infusion of dextrose to maintain blood glucose concentration (to maintain euglycemia).
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Study Visit | Experimental | Participants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest. Receives: Other: Hyperinsulinemic-euglycemic Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions
Liquid chromatography tandem mass spectrometry (targeted lipidomics) will be used to assess species-level changes in skeletal muscle lipid content in biopsy samples collected before and after the insulin infusion to induce mild hyperinsulinemia.
Measured: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Secondary outcomes (1)
Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions
High-resolution respirometry will be used to assess changes in skeletal muscle mitochondrial oxidative capacity in biopsy samples collected before and after the insulin infusion to induce mild hyperinsulinemia.
Measured: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start22 Feb 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Why it stopped: Unsuccessful enrollment during COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be asked to complete 1 screening visit to determine eligibility. If participants remain eligible, they will be asked to complete 1 metabolic study visit.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Newsom, Oregon State University
- Investigators
- Sean A Newsom, Ph.D., Principal investigator, Oregon State UniversityMatthew M Robinson, Ph.D., Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759872
- Sponsor's protocol ID
- IRB-2020-0768
- Status last verified
- Jun 2022
- First submitted
- 9 Feb 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin and Muscle Fat Metabolism
- ClinicalTrials.gov ID
- NCT04759872
- Acronym / sponsor ID
- IRB-2020-0768
- Conditions
- Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful enrollment during COVID-19 pandemic.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- 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.
Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be asked to complete 1 screening visit to determine eligibility. If participants remain eligible, they will be asked to complete 1 metabolic study visit.
| Arm | Type | Receives |
|---|---|---|
| Metabolic Study Visit | Experimental | Other: Hyperinsulinemic-euglycemic ClampParticipants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 30-55 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Key exclusion criteria (9 listed)
- Regular exercise (>1 hour of planned exercise per week)
- Smoking, tobacco or nicotine use within the last 1-year
- Fasting glucose >126mg/dL
- Hypertension (systolic pressure >140 mmHg or diastolic pressure >90 mmHg)
- Chronic metabolic or cardiovascular health conditions
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 |
|---|---|---|
| Hyperinsulinemic-euglycemic ClampParticipants will be administered a constant-rate insulin infusion (to induce mild hyperinsulinemia), with an infusion of dextrose to maintain blood glucose concentration (to maintain euglycemia). | Other | Metabolic Study Visit |
Primary outcome
Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions
Time frame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Liquid chromatography tandem mass spectrometry (targeted lipidomics) will be used to assess species-level changes in skeletal muscle lipid content in biopsy samples collected before and after the insulin infusion to induce mild hyperinsulinemia.
1 secondary outcome
Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions
Time frame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Results and safety
The study was stopped early (reason given: Unsuccessful enrollment during COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Sean A Newsom, Ph.D. principal investigator
Oregon State University
Matthew M Robinson, Ph.D. principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic-euglycemic Clamp in people with Overweight and Obesity and Insulin Resistance, run by Oregon State University 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Jun 2022. 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 was stopped early (reason given: Unsuccessful enrollment during COVID-19 pandemic.). Results are not available in the source record.
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?
Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions (time frame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit). 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 10 Jun 2022.