Intralipid for Insulin Resistance

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Insulin Resistance
Intralipid - DietarySupplement
Eligibility
18 - 65
All Sexes
Eligible conditions
Insulin Resistance

Study Summary

Intramyocellular Fatty Acid Trafficking in Insulin Resistance States - Effects of Intestinal Delivery of Lipids

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Intralipid will improve 1 primary outcome in patients with Insulin Resistance. Measurement will happen over the course of 18 hours.

18 hours
Change in fatty acid enrichment of intramyocellular signaling molecules before and after a euglycemic, hyperinsulinemic clamp

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Saline
Palm Oil
Placebo group

This trial requires 24 total participants across 3 different treatment groups

This trial involves 3 different treatments. Intralipid is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Palm Oil
DietarySupplement
Intralipid
DietarySupplement
Saline
Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intralipid
2013
Completed Phase 4
~1070

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 hours for reporting.

Who is running the study

Principal Investigator
M. D. J.
Michael D. Jensen, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women and Men (Women premenopausal)
BMI 18-27
Weight stable
Not pregnant/nursing

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of insulin resistance?

Add answer

The signs of IR include high levels of glucose in the blood, low levels of HDL, and high levels of triglycerides. Symptoms of IR may include insulin resistance, insulin resistance, low-grade inflammation (elevated CRP), and elevated blood glucose.\n

Unverified Answer

What causes insulin resistance?

Add answer

Insulin resistance may partially be a result of an abnormal gene and protein composition. However, other factors including poor dietary fat and protein intakes and the activity of other hormones are also likely to contribute to the rise in type 2 diabetes mellitus.

Unverified Answer

What are common treatments for insulin resistance?

Add answer

Multiple treatments are given to subjects with insulin resistance. Insulin resistance is also treated more aggressively. Subjects with insulin resistance usually have additional health problems.

Unverified Answer

How many people get insulin resistance a year in the United States?

Add answer

About 11 million cases of insulin resistance are diagnosed annually in patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes). At least 3 million cases of insulin resistance are associated with non-insulin-dependent diabetes mellitus.

Unverified Answer

Can insulin resistance be cured?

Add answer

Hyperinsulism is a frequent and profound feature of many chronic medical diseases. The treatment of hyperinsulinemia has been a challenge to clinicians, but the role of insulin as an endocrine regulator has been a major focus of research. The present study demonstrates that insulin-specific T cells exist and that such T cells infiltrate pancreatic β-cells in rats with insulin resistance, but not in normal-fat control rats. Recent findings suggest that T cells are implicated in the development of insulin resistance.

Unverified Answer

What is insulin resistance?

Add answer

In contrast to other ethnic groups with the same average height as Caucasians, the prevalence of insulin resistance is very low among Egyptian men. This observation needs to be validated in other geographic regions.

Unverified Answer

Have there been other clinical trials involving intralipid?

Add answer

Recent findings demonstrate a higher rate of diabetes development in patients with lower levels of insulin and a higher insulin sensitivity that is associated with intralipid therapy. Recent findings from the current study have led us to believe there may need to be a new clinical trial regarding the intramuscular administration of intralipid to ascertain if there is a link between this lipid and the pathogenesis of diabetes.

Unverified Answer

How serious can insulin resistance be?

Add answer

Contrary to our hypothesis, insulin resistance was not related to body fatness but rather to other variables such as fasting insulin levels, HOMA insulin resistance index, and insulin sensitivity. More research is needed to define the role of insulin resistance in the pathogenesis of type 2 diabetes, particularly in relation to obesity.

Unverified Answer

Who should consider clinical trials for insulin resistance?

Add answer

Our analysis demonstrated that a large number of patients were not eligible before enrollment to any clinical trial for IR. Insulin resistance has several risk factors for development and progression to T1DM. Clinical trials regarding IR should take into account these patient subgroups; the results from the current or future studies on IR may alter clinical interventions.

Unverified Answer

What is the primary cause of insulin resistance?

Add answer

The primary cause of insulin resistance are genetic factors. In all cases of insulin resistance, our patients were found to have abnormalities in either glucose or lipid metabolism (in their blood). However, the mechanisms of insulin sensitization are still unclear. It is hoped that a better understanding of these mechanisms may lead to better treatments in the future. ClinicalTrials.gov (http://clinicaltrials.gov) lists multiple ongoing clinical trials. Please contact your local clinical trial liaison to learn more about these trials. At the moment, we are trying to understand how the different treatments affect glucose or lipid metabolism.

Unverified Answer

Is intralipid typically used in combination with any other treatments?

Add answer

Intralipid as part of treatment for PHT is very effective in reducing LDL-C levels. Data from a recent study, however, the use of insulin, oral antidiabetic agents, statins and metformin does not significantly enhance the LDL-C lowering efficacy of intralipid. If these medications are necessary for a patient experiencing severe hypercholesterolaemia during treatment with intralipid, their use should be initiated at least 4 weeks before the start of intralipid therapy.

Unverified Answer

What is the latest research for insulin resistance?

Add answer

Researchers in Canada have found that there was a significant link between a number of genes and insulin resistance; however, they have also found that different genes determine the onset of the disease. Therefore, the onset of insulin resistance is only partially inherited; the other determinants of insulin resistance can be partially inherited, but their inheritance is a whole range of genes, including genes that have been found to be associated with obesity. The study also found, from the evidence, that genetic risk alone is not enough. The risk conferred by any single gene varies between the different genes, with some genes influencing insulin resistance more than others.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Insulin Resistance by sharing your contact details with the study coordinator.