Insulin Resistance in the Control of Intestinal Lipid Metabolism
NCT ID: NCT02020343
Last Updated: 2016-08-19
Study Results
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.
COMPLETED
22 participants
OBSERVATIONAL
2014-01-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
NCT03189121
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
NCT04309071
Metabolic Effect of New Foods Through Gut-brain Axis
NCT01851304
Does Class of Dietary Fat Affect Insulin Resistance?
NCT01541592
Pilot Study to Test Dietary Fat Delivery
NCT02101996
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
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
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
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Missouri-Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth Parks
Professor
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
Countries
Review the countries where the study has at least one active or historical site.
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.
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.