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SFA versus control diet for Insulin Resistance

N/A
Waitlist Available
Led By Peter D Reaven, MD
Research Sponsored by Phoenix VA Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 150-180 min
Awards & highlights

Study Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~150-180 min
This trial's timeline: 3 weeks for screening, Varies for treatment, and 150-180 min for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Steady-state plasma glucose (SSPG)
Secondary outcome measures
Acylcarnitine species
Ceramides species
Diacylglycerol species
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: SFA versus control dietExperimental Treatment1 Intervention
Participants will be randomized in a cross-over design to either a weight-maintaining, nutritionally-balanced American Heart Association based eucaloric control diet or a high calorie 24-hour saturated fatty acids enriched diet. For the control diet participants will follow a dietary plan for 72 hours prior to testing. For the SFA diet, participants will be provided with high caloric liquid shakes for breakfast, lunch, dinner and a bedtime snack. On the morning of each test day, participants will be admitted in the fasting state and will provided with a breakfast meal corresponding to the assigned diet (SFA or control). Three hours after completion of the meal, insulin sensitivity will be measured by insulin-suppression test (IST).
Group II: MUFA versus control dietExperimental Treatment1 Intervention
Participants will be randomized in a cross-over design to either a weight-maintaining, nutritionally-balanced American Heart Association based eucaloric control diet or a high calorie 24-hour monounsaturated fatty acids (MUFA) enriched diet. For the control diet participants will follow a dietary plan for 72 hours prior to testing. For the MUFA diet, participants will be provided with high caloric liquid shakes for breakfast, lunch, dinner and a bedtime snack. On the morning of each test day, participants will be admitted in the fasting state and will provided with a breakfast meal corresponding to the assigned diet (MUFA or control). Three hours after completion of the meal, insulin sensitivity will be measured by insulin-suppression test (IST).
Group III: CARB versus control dietExperimental Treatment1 Intervention
Participants will be randomized in a cross-over design to either a weight-maintaining, nutritionally-balanced American Heart Association based eucaloric control diet or a high calorie 24-hour carbohydrate (CARB) enriched diet. For the control diet participants will follow a dietary plan for 72 hours prior to testing. For the CARB diet, participants will be provided with high caloric liquid shakes for breakfast, lunch, dinner and a bedtime snack. On the morning of each test day, participants will be admitted in the fasting state and will provided with a breakfast meal corresponding to the assigned diet (CARB or control). Three hours after completion of the meal, insulin sensitivity will be measured by insulin-suppression test (IST).

Find a Location

Who is running the clinical trial?

Phoenix VA Health Care SystemLead Sponsor
12 Previous Clinical Trials
1,175 Total Patients Enrolled
1 Trials studying Insulin Resistance
35 Patients Enrolled for Insulin Resistance
Peter D Reaven, MDPrincipal InvestigatorPhoenix Veterans Affairs Health Care System
5 Previous Clinical Trials
1,369 Total Patients Enrolled
1 Trials studying Insulin Resistance
35 Patients Enrolled for Insulin Resistance

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Dietary Lipid Induced Insulin Resistance
2012. "Dietary Lipid Induced Insulin Resistance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02757560.
~23 spots leftby Apr 2025
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