Diabetes Mellitus, Type 2Early Phase 1BCAANCT03479671
Low Dose Fat-Induced Insulin Resistance
A Early Phase 1 study testing Intralipid, 20% Intravenous Emulsion in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Insulin Sensitivity
- What is being tested?
- Intralipid, 20% Intravenous Emulsion
- 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
- 1 Jan 2020to 19 Nov 2024
- Phase
- Early 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol
Who cannot join
- History of diabetes
- History of diabetes in more than one first-degree relative
- Body mass index (BMI) <19 or >27 kg/m2
- HbA1c >5.7%
- Blood Pressure: systolic >160 mmHg or diastolic > 100 mmHg
- Baseline hemoglobin concentration < 11 g/dl in women and < 12 g/dl in men
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- Estimated glomerular filtration rate < 55 ml/min/1.73 m2 (calculated using the subject's measured serum creatinine and the Modification of Diet in Renal Disease [MDRD] study estimation formula).
- Presence of soy or egg allergies (due to possible reactions with fat infusate)
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
- Known active alcohol or substance abuse
- Use of tobacco within the previous year
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- history of myocardial infarction within past 6 months;
- history of ischemia on functional cardiac exam within the last year;
- history of left ventricular ejection fraction < 30%.
- Persistent elevation of liver function tests > 1.5 times normal upper limits
- Hyperlipidemia (fasting LDL cholesterol > 130 mg/dl, treated or untreated; and/or fasting triglycerides > 200 mg/dl)
- Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤ 5 mg prednisone daily, or an equivalent physiological dose of hydrocortisone
- Presence of a seizure disorder
- Use of any investigational agents within 4 weeks of enrollment
- Any medical condition, which in the opinion of the investigator, will interfere with the safe completion of the study
- History of pancreatitis
- Presence of a metal allergy (aluminum)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers
The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid infusion that reliably causes mild insulin resistance will be selected for use in future studies.
Read the detailed description
This study is designed to test the hypothesis that a low-dose of fatty acid infusion (Intralipid/heparin) will cause mild insulin resistance. This dose-finding study is critical for future studies on free-fatty acid induced insulin resistance.
Healthy male and healthy female volunteers will undergo a 6 hour hyperinsulinemic-euglycemic clamp, in order to establish insulin sensitivity parameters in the presence of fatty acid co-infusion. The subjects will then return 1-3 weeks later, and undergo another 6 hour HIE clamp, this time in the presence of low-dose fatty acid co-infusion (30ml/hr). If this dose does not achieve ~25% reduction in the rate of glucose disposal, then the dose-confirmation study will be repeated 1-3 weeks later with a medium-dose fatty acid co-infusion (60ml/hr).
A dose-response effect of fatty acids on insulin resistance has been demonstrated before, but not in the precise conditions of our study. This dose-finding study is critical because future studies require a reliable dose of fatty acid infusion, and the exact dose of fatty acid infusion that causes mild insulin resistance may be different in the conditions of our study.
- Being tested
- Intralipid, 20% Intravenous Emulsion
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid, 20% Intravenous EmulsionDrug
Fatty Acid Infusion, either in low-dose (30 ml/hr) or medium-dose (60 ml/hr)
| Study group | Role | What they receive |
|---|---|---|
| Saline | No intervention | Insulin sensitivity (rate of glucose disposal) |
| Low Dose Fatty Acids | Experimental | Insulin sensitivity (rate of glucose disposal) in response to 30 ml/hr fatty acid infusion Receives: Drug: Intralipid, 20% Intravenous Emulsion |
| Medium Dose Fatty Acids | Experimental | Insulin sensitivity (rate of glucose disposal) in response to 60 ml/hr fatty acid infusion Receives: Drug: Intralipid, 20% Intravenous Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Rate of Glucose Disposal (mg/kg/min)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2020
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Baseline insulin sensitivity will be measured in healthy volunteers, and then 1-3 weeks later insulin sensitivity will be measured in response to a low-dose fatty acid infusion. If there is no response to this low-dose infusion, then 1-3 weeks later insulin sensitivity will be measured in response to a medium-dose fatty acid infusion.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoltan Arany, University of Pennsylvania
- Investigators
- Zoltan P Arany, MD, PhD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479671
- Sponsor's protocol ID
- 831425
- Acronym
- BCAA
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2018
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03479671
- Acronym / sponsor ID
- BCAA / 831425
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 27 Mar 2018 (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.
The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid infusion that reliably causes mild insulin resistance will be selected for use in future studies.
Detailed description
This study is designed to test the hypothesis that a low-dose of fatty acid infusion (Intralipid/heparin) will cause mild insulin resistance. This dose-finding study is critical for future studies on free-fatty acid induced insulin resistance.
Healthy male and healthy female volunteers will undergo a 6 hour hyperinsulinemic-euglycemic clamp, in order to establish insulin sensitivity parameters in the presence of fatty acid co-infusion. The subjects will then return 1-3 weeks later, and undergo another 6 hour HIE clamp, this time in the presence of low-dose fatty acid co-infusion (30ml/hr). If this dose does not achieve ~25% reduction in the rate of glucose disposal, then the dose-confirmation study will be repeated 1-3 weeks later with a medium-dose fatty acid co-infusion (60ml/hr).
A dose-response effect of fatty acids on insulin resistance has been demonstrated before, but not in the precise conditions of our study. This dose-finding study is critical because future studies require a reliable dose of fatty acid infusion, and the exact dose of fatty acid infusion that causes mild insulin resistance may be different in the conditions of our study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Baseline insulin sensitivity will be measured in healthy volunteers, and then 1-3 weeks later insulin sensitivity will be measured in response to a low-dose fatty acid infusion. If there is no response to this low-dose infusion, then 1-3 weeks later insulin sensitivity will be measured in response to a medium-dose fatty acid infusion.
| Arm | Type | Receives |
|---|---|---|
| Saline | No intervention | –Insulin sensitivity (rate of glucose disposal) |
| Low Dose Fatty Acids | Experimental | Drug: Intralipid, 20% Intravenous EmulsionInsulin sensitivity (rate of glucose disposal) in response to 30 ml/hr fatty acid infusion |
| Medium Dose Fatty Acids | Experimental | Drug: Intralipid, 20% Intravenous EmulsionInsulin sensitivity (rate of glucose disposal) in response to 60 ml/hr fatty acid infusion |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol
Key exclusion criteria (23 listed)
- History of diabetes
- History of diabetes in more than one first-degree relative
- Body mass index (BMI) <19 or >27 kg/m2
- HbA1c >5.7%
- Blood Pressure: systolic >160 mmHg or diastolic > 100 mmHg
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 |
|---|---|---|
| Intralipid, 20% Intravenous EmulsionFatty Acid Infusion, either in low-dose (30 ml/hr) or medium-dose (60 ml/hr) | Drug | Low Dose Fatty Acids, Medium Dose Fatty Acids |
Primary outcome
Insulin Sensitivity
Time frame: 6 hours
Rate of Glucose Disposal (mg/kg/min)
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 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zoltan P Arany, MD, PhD principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intralipid, 20% Intravenous Emulsion in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Pennsylvania 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 1 inclusion and 23 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 15 Apr 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Insulin Sensitivity (time frame: 6 hours). 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 15 Apr 2026.