Dietary Lipid Induced Insulin Resistance

Status unconfirmed · Not applicable

Conditions studied: Insulin Resistance

In brief

The overall goal of the proposal is to use a saturated fatty acid (SFA)- enriched, high fat diet to rapidly induce insulin resistance (IR) to provide insight into underlying proximal mechanisms of reduced insulin signaling. Specifically, investigators will identify the initial changes in metabolite concentrations/or pathway signaling ("pathways" will be used to broadly refer to these mechanism specific measures) and therefore the mechanisms most likely responsible for the development of IR during this high fat nutritional challenge. Investigators have assembled a multidisciplinary team that is versed with dietary studies, fatty acid metabolism, measurement of IR and potential mechanisms and mediators of IR, and has experience working with monocytes and the two tissues, muscle and adipose tissue, that are particularly relevant for understanding the effects of high fat diets on IR.

Key facts

Study ID

NCT02757560

Run by

Phoenix VA Health Care System

People needed

300

Starts

2012-02-01

Expected to finish

2020-12-01

Last updated by the study team

2019-08-01

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index (BMI) from 25-35 kg/m2
• normal glucose tolerance (NGT) diagnosis based on fasting glucose value 100mg/dl and 2 hr glucose <140 mg/dl after a standard 75 gm glucose load; impaired fasting glucose (IFG) on fasting glucose value ≥100 and <126 mg/dl and 2 hr glucose <140 mg/dl; impaired glucose tolerance (IGT) based on 2 hr glucose ≥140 and <200 mg/dl and a fasting glucose <126 mg/dl
• Fasting triglyceride levels <500 mg/dl

You may not qualify if…

• Type 1 or 2 diabetes mellitus or a hemoglobin A1c value ≥ 6.5 mg/dl
• Any diabetes medications in the past month, thiazolidinedione medications in the prior 3 months or prior regular use of insulin
• Use of diets, medications (e.g., steroids, weight loss medications ) or current or planned behavior changes (e.g. acute weight loss, exercise training) that will influence changes in IR
• Creatinine >2.0 mg/dl or other laboratory evidence of significant active disease, including hepatic enzyme elevation >2x normal and anemia, known "Nonalcoholic Fatty Liver Disease", bleeding risk
• Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems, or recent history of nausea or vomiting
• Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
• Cardiovascular event, stable or unstable angina or other major illness in the past 6 months
• Current regular use of anti-inflammatory medications (e.g. salicylates > 1 gm/ day) or antioxidants in excess of a daily multi-vitamin, including supplements (e.g. fish oils)
• Lipid lowering medications must be at a stable dose for at least 2 months prior to participation
• Ethanol consumption more than 4 oz day; more than occasional smoker
• Reproductively active women not on contraceptives
• Known allergies, prior reactions or contraindications to proposed clinical agents (e.g Octreotide)

Where it is running

• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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