RECRUITING

Low Dose Fat-Induced Insulin Resistance

Conditions

Diabetes Mellitus, Type 2 Insulin Resistance Insulin Sensitivity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Dose Finding Study for Fat-Induced Insulin Resistance in Healthy Volunteers

Quick Facts

Study Start:2020-01-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03479671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol	* 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)

Inclusion Criteria

Exclusion Criteria

* Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol

* 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)

Contacts and Locations

Study Contact

Paola Alvarado, MS

CONTACT

215-746-2081

Paola.Alvarado@Pennmedicine.upenn.edu

Michael D Neinast, BS

CONTACT

469-323-7470

mneinast@pennmedicine.upenn.edu

Principal Investigator

Zoltan P Arany, MD, PhD

PRINCIPAL_INVESTIGATOR

Associate Professor of Medicine

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Zoltan P Arany, MD, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2020-01-01

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Insulin Resistance
Insulin Sensitivity