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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

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.


Condition or disease Intervention/treatment
Insulin Resistance Type 2 Diabetes Behavioral: taste tests

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.


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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Insulin Resistance in the Control of Intestinal Lipid Metabolism
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy
Not insulin resistant
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.

Insulin resistant
Insulin resistant by IVGTT
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.

Type 2 diabetics
Type 2 diabetics
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.




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
DNA will be collected for future determination of genotypes that impact taste senstivity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, insulin resistant and type 2 diabetic subjects.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020343


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Elizabeth J Parks, PhD University of Missouri-Columbia

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Responsible Party: Elizabeth Parks, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02020343     History of Changes
Other Study ID Numbers: 1208668
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs