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Dietary Supplement
Fatty Acid Interventions for Insulin Resistance
N/A
Recruiting
Led By Michael D Jensen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 hours
Awards & highlights
Study Summary
This trial will study the effects of different types of fat on muscle insulin resistance.
Who is the study for?
This trial is for healthy, non-obese adults with a BMI of 18-27 who are not pregnant or nursing and have maintained their weight. Women must be premenopausal. It excludes those on certain lipid-altering meds, smokers, individuals with specific heart diseases or lidocaine allergy.Check my eligibility
What is being tested?
The study tests how palm oil emulsion and Intralipid infusions affect muscle insulin resistance by altering fatty acid profiles in the body compared to saline control. It aims to understand how these fats impact insulin signaling and glucose uptake in muscles.See study design
What are the potential side effects?
While the side effects are not explicitly listed, interventions involving intraduodenal infusion may cause digestive discomfort, nausea, potential allergic reactions or changes in blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fatty acid enrichment of intramyocellular signaling molecules before and after a euglycemic, hyperinsulinemic clamp
Side effects data
From 2022 Phase 4 trial • 101 Patients • NCT0455504444%
HYPERBILIRUBINAEMIA NEONATAL
30%
PATENT DUCTUS ARTERIOSUS
28%
ANAEMIA NEONATAL
14%
FEEDING INTOLERANCE
12%
INTRAVENTRICULAR HAEMORRHAGE NEONATAL
10%
NEONATAL HYPONATRAEMIA
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
ATRIAL SEPTAL DEFECT
10%
SEPSIS NEONATAL
10%
INFANTILE APNOEA
6%
BRADYCARDIA NEONATAL
6%
URINARY TRACT INFECTION
4%
HYDROCELE
4%
ADRENAL INSUFFICIENCY NEONATAL
4%
Vomiting
4%
HYPERNATRAEMIA
4%
BLOOD TRIGLYCERIDES INCREASED
4%
BRONCHOPULMONARY DYSPLASIA
4%
HAEMATOCHEZIA
4%
GASTROOESOPHAGEAL REFLUX DISEASE
4%
HYPERCHLORAEMIA
4%
DERMATITIS DIAPER
4%
OSTEOPENIA
2%
NECROTISING ENTEROCOLITIS NEONATAL
2%
POSTOPERATIVE RESPIRATORY FAILURE
2%
ACUTE RESPIRATORY FAILURE
2%
INFUSION SITE EXTRAVASATION
2%
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
2%
HYPOVOLAEMIA
2%
VENTRICULAR TACHYCARDIA
2%
NEWBORN PERSISTENT PULMONARY HYPERTENSION
2%
HYPOTHYROIDISM
2%
CARDIOVASCULAR EXAMINATION ABNORMAL
2%
MECONIUM PLUG SYNDROME
2%
EYE DISCHARGE
2%
URINARY TRACT INFECTION FUNGAL
2%
HYDROCEPHALUS
2%
ANAL FISSURE
2%
URINARY TRACT INFECTION NEONATAL
2%
RENAL INJURY
2%
ADMINISTRATION SITE EXTRAVASATION
2%
ABDOMINAL DISTENSION
2%
HYPERGLYCAEMIA
2%
HYPERMAGNESAEMIA
2%
EYE INFECTION
2%
NEONATAL RESPIRATORY DISTRESS SYNDROME
2%
PNEUMOTHORAX
2%
GASTRIC FLUID ANALYSIS ABNORMAL
2%
PHYTOSTEROL LEVEL INCREASED
2%
FREE FATTY ACIDS DECREASED
2%
RASH ERYTHEMATOUS
2%
DYSPNOEA
2%
STRIDOR
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clinolipid (Lipid Injectable Emulsion) 20%
Intralipid (SOC Soybean Oil-based Lipid Emulsion)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Palm OilExperimental Treatment1 Intervention
Group II: IntralipidExperimental Treatment1 Intervention
Group III: SalinePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intralipid
2013
Completed Phase 4
~1220
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,181 Total Patients Enrolled
87 Trials studying Insulin Resistance
13,165 Patients Enrolled for Insulin Resistance
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,080 Total Patients Enrolled
20 Trials studying Insulin Resistance
766 Patients Enrolled for Insulin Resistance
Michael D Jensen, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking certain medications that can change the levels of fat in your blood.You smoke more than 20 cigarettes per week.Both ovaries have been removed.You have a condition called ischemic heart disease.You are allergic to lidocaine.This applies to both women and men, including women who have not gone through menopause.Your body mass index (BMI) is between 18 and 27.You have not experienced significant changes in your weight recently.You have heart valve disease caused by atherosclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Palm Oil
- Group 2: Intralipid
- Group 3: Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project include elderly individuals among its participants?
"To be eligible, participants must fall between the ages of 18 and 55."
Answered by AI
Who is best suited to serve as subjects in this research experiment?
"To be enrolled in this study, participants must have insulin resistance and fall into the range between 18 to 55 years old. 24 individuals are being sought after for recruitment."
Answered by AI
How many participants are being administered treatment through this trial?
"Affirmative. According to clinicaltrials.gov, this research project is currently in the process of accepting applicants. It was initially posted on December 1st 2018 and has been recently updated on April 13th 2022 and is actively recruiting for 24 participants at a single site."
Answered by AI
Is this trial still enrolling participants?
"As indicated on clinicaltrials.gov, this medical investigation is actively searching for participants. The trial was first made visible to the public on December 1st 2018 and has been revised as recently as April 13th 2022."
Answered by AI
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