Insulin ResistanceNCT02020343
Insulin Resistance in the Control of Intestinal Lipid Metabolism
An observational study of Insulin Resistance and Type 2 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- taste tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy, insulin resistant and type 2 diabetic subjects.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- taste tests
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taste testsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Healthy | Not insulin resistant Receives: Behavioral: taste tests | |
| Insulin resistant | Insulin resistant by IVGTT Receives: Behavioral: taste tests | |
| Type 2 diabetics | Type 2 diabetics Receives: Behavioral: taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal triglyceride (TG) absorption
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
Measured: Change in plasma TG concentrations over 24 hr after meals and in response to an acute sensory stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Parks, University of Missouri-Columbia
- Investigators
- Elizabeth J Parks, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020343
- Sponsor's protocol ID
- 1208668
- Status last verified
- Aug 2016
- First submitted
- 13 Dec 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34369385
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in the Control of Intestinal Lipid Metabolism
- ClinicalTrials.gov ID
- NCT02020343
- Acronym / sponsor ID
- 1208668
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Behavioral: taste testsNot insulin resistant |
| Insulin resistant | – | Behavioral: taste testsInsulin resistant by IVGTT |
| Type 2 diabetics | – | Behavioral: taste testsType 2 diabetics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, insulin resistant and type 2 diabetic subjects.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taste testsSubjects 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. | Behavioural | Healthy, Insulin resistant, Type 2 diabetics |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 34369385Jacome-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Parks, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Type 2 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meal triglyceride (TG) absorption (time frame: Change in plasma TG concentrations over 24 hr after meals and in response to an acute sensory stimulus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.