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Fat infusion study aims to unlock diabetes clues

NCT ID NCT03479671

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed early-phase study tested different doses of fatty acids (Intralipid) in 9 healthy volunteers to find the dose that causes mild insulin resistance. The goal was to create a reliable model for future diabetes research. Participants received low or medium doses of fat infusion, and their insulin sensitivity was measured.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intralipid (fatty acid infusion)
What this could lead to
If successful, this could help researchers design better studies on how fat affects insulin resistance, potentially leading to new diabetes treatments.
What could go wrong
This is a very small, early-phase study with only 9 healthy volunteers, so results may not apply to people with diabetes or other conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

9 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 44 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol Exclusion Criteria: * 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 * 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: 1. history of myocardial infarction within past 6 months; 2. history of ischemia on functional cardiac exam within the last year; 3. 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)

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Conditions

The condition(s) this trial relates to.

Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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