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Insulin Resistance in the Control of Intestinal Lipid Metabolism

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ClinicalTrials.gov Identifier: NCT02020343
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth Parks, University of Missouri-Columbia

Tracking Information
First Submitted Date December 13, 2013
First Posted Date December 24, 2013
Last Update Posted Date August 19, 2016
Study Start Date January 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2013)
Meal triglyceride (TG) absorption [ Time Frame: Change in plasma TG concentrations over 24 hr after meals and in response to an acute sensory stimulus ]
In vivo measurement of meal TG absorption is made using stable isotope administration into sequential meals (lunch and dinner) and analysis of plasma samples by GS/MS
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02020343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Insulin Resistance in the Control of Intestinal Lipid Metabolism
Official Title Insulin Resistance in the Control of Intestinal Lipid Metabolism
Brief Summary

America's preferential consumption of high-fat/high-sugar foods is a driving force in the current epidemic of obesity and insulin resistance. Recent scientific observations suggest that the taste of food may play a role in how the body processes the food eaten in a meal. The intestine may play a central role in all aspects of dietary fat metabolism, from initial encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body.

The investigators hypothesize that elevated blood fats in insulin resistance are a result of elevated intestinal-TG secretion and poor communication of this organ to the rest of the body after meals.

In this study, meal feeding and sensory studies will be performed to determine whether the mechanism of taste-associated intestinal signaling leads to higher levels of blood fats after meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will consume special meals the night before the tests and participate in sensory tests in the morning to analyze the effect of taste.

The goal of this work is to understand how insulin resistance may cause impaired signaling between the taste buds and the intestine to result in an elevation in blood lipids, which increases the risk for other chronic diseases. This study will generate data for a future study to understand how diabetes treatment affects this process.

Detailed Description

Subjects will participate in two screening visits to determine insulin resistance status and then participate in a single in-patient, clinical research center test.

There are no drugs used in this study. The goal is to test the physiological response to eating.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA will be collected for future determination of genotypes that impact taste senstivity
Sampling Method Non-Probability Sample
Study Population Healthy, insulin resistant and type 2 diabetic subjects.
Condition
  • Insulin Resistance
  • Type 2 Diabetes
Intervention Behavioral: taste tests
Subjects undergo "sham feeding" in which they take a bit of food, chew it and spit it out. This test should engage sensory mechanisms which may affect intestinal signaling.
Study Groups/Cohorts
  • Healthy
    Not insulin resistant
    Intervention: Behavioral: taste tests
  • Insulin resistant
    Insulin resistant by IVGTT
    Intervention: Behavioral: taste tests
  • Type 2 diabetics
    Type 2 diabetics
    Intervention: Behavioral: taste tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 17, 2016)
22
Original Estimated Enrollment
 (submitted: December 18, 2013)
24
Actual Study Completion Date August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Healthy subjects (age 18-50y) will be categorized as:

  • lean/insulin sensitive (IS) (n=8, BMI </= 24 kg/m2 and SI ≥ 2.5 min-1 10-4 * per uU/mL)
  • overweight/obese IS (n=8, BMI 26-35 and SI >2.5 min-1 10-4 * per uU/mL)
  • overweight/obese insulin resistant (n=8, BMI 26-35 and SI <2.5 min-1 10-4 * per uU/mL).

Overweight/obese insulin resistant subjects will have a family history of diabetes as defined as at least one parent or grandparent with type 2 diabetes, or at least one other family member with type 2 diabetes.

  • Type 2 diabetic patients (BMI 26-35, and OGTT 2h glucose >/= 140 mg/dL.

Exclusion Criteria:

  • BMI over 35 kg/m2: We felt it prudent to limit the additional variability that could be caused by morbid obesity (and by diabetes), given the early stages of this research area.
  • Unusual eating habits (dietary fat< 30% or >40% of energy, skipping breakfast, day-long fasting, or allergies to milk). Habitual food intake can influence taste acuity and milk is used in the formulas to dissolve the isotopes.
  • Uncontrolled hypertension, or occasional or regular smoker, use of supplements or medications that interfere with lipid, protein, or carbohydrate metabolism or impact taste. For example, the hypertensive drugs thiazides or the supplement chondroitin sulfate or niacin, can be associated with impaired glucose tolerance. ACE inhibitors and beta-blockers and smoking can affect taste. Use of insulin in the case of type 2 diabetics.
  • Pregnancy (urine test), breastfeeding, or anemia (CBC with diff): Limitations of blood that can be drawn. Postmenopausal women frequently have increases in blood lipids since lack of estrogen influences lipid metabolism.
  • Alcohol intake: Males >140 g/week, females > 70 g/week. Excess EtOH increases lipid synthesis and secretion in the liver and whether it also has an impact on intestinal TG metabolism is unknown.
  • Fasting plasma TG >300 mg/dL. Extreme hypertriglyceridemia could be due to either elevations in VLDL or chylomicrons, either of which would impair our ability to resolve dietary metabolic processes.
  • Exclude those who need to consume acetaminophen-containing medications on a regular basis. Acetaminophen is administered with meals to assess gastric emptying.
  • Postmenopausal women.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02020343
Other Study ID Numbers 1208668
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elizabeth Parks, University of Missouri-Columbia
Study Sponsor University of Missouri-Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Elizabeth J Parks, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date August 2016