Insulin Resistance in the Control of Intestinal Lipid Metabolism

NCT ID: NCT02020343

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

Not insulin resistant

taste tests

Intervention Type BEHAVIORAL

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

taste tests

Intervention Type BEHAVIORAL

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

taste tests

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elizabeth Parks

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth J Parks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Missouri

Columbia, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Jacome-Sosa M, Hu Q, Manrique-Acevedo CM, Phair RD, Parks EJ. Human intestinal lipid storage through sequential meals reveals faster dinner appearance is associated with hyperlipidemia. JCI Insight. 2021 Aug 9;6(15):e148378. doi: 10.1172/jci.insight.148378.

Reference Type DERIVED
PMID: 34369385 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1208668

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Insulin Resistance and Reward
NCT02241603 COMPLETED PHASE2
Insulin Resistance Study
NCT00614757 SUSPENDED NA