Obstructive Sleep ApneaNCT02157844
Fat Metabolism in OSA and COPD
An observational study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by Texas A&M University at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia and re-oxygenation, which lead to increased oxidative stress, increased inflammation, endothelial dysfunction, and insulin resistance. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Obesity
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2017
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with OSA or COPD will be recruited when visiting a medical or pulmonary clinic in and outside the surrounding area of College Station. Patients and healthy subjects will also be recruited by responding to distributed flyers in the community in the College Station area; for example in hospital/clinic waiting areas, clinic rooms and bulletin boards at Scott \& White and the CSMC or any other hospital. Other general recruitment material in relation to the nutrition research that the research group performs at Texas A\&M can be placed on bulletin boards at Scott \& White and the CSMC.
Who may be able to join
- Established diagnosis of OSA or COPD
- Ability to sign informed consent
- Ability to walk, sit down and stand up independently
- Age 30 years and older
- Ability to lie in supine position for up to 8 hours
- Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease
Show all 14Show fewer
- Willingness and ability to comply with the protocol
- Inclusion criteria healthy normal weight and obese subjects:
- Healthy male \& female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 30 years or older
- Ability to lay in supine or elevated position for 8 hours
- No diagnosis of OSA or COPD
- Willingness and ability to comply with the protocol
Who cannot join
- Established diagnosis of malignancy
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
Show all 13Show fewer
- Use of protein or amino acid containing nutritional supplements within 5 days of first study day 5 days of first study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
- Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
- Recent myocardial infarction ( < 1 year ago)
- Current alcohol or drug abuse
- (Possible) pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fat Metabolism and Digestion in Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia and re-oxygenation, which lead to increased oxidative stress, increased inflammation, endothelial dysfunction, and insulin resistance. Chronic obstructive pulmonary disease (COPD) is a lung disease that leads to poor airflow. This disease leads to systemic hypoxia, reduced oxidative capacity, and increased inflammation. The direct cause of OSA and COPD is unclear, but OSA and COPD may be linked to other comorbid conditions such as obesity and type II diabetes. Upon onset of OSA and COPD, metabolic disturbances associated with obesity and type II diabetes can be exacerbated.
Obesity is a condition characterized by an increase in visceral fat, elevated plasma levels of free fatty acids, inflammation, and insulin resistance. Although the effects of body fat distribution have not been studied in these patients, an increase in both subcutaneous and abdominal fat mass in non-OSA older women was shown to increase morbidity and mortality. Fat/adipose tissue is an active tissue capable of secreting proinflammatory cytokines such as tumor necrosis factor (TNF)-alpha and interleukin (IL)-6, reactive oxygen species and adipokines. Particularly, abdominal fat is a prominent source of pro-inflammatory cytokines, which contributes to a low grade, chronic inflammatory state in these patients. Additionally, an increased inflammatory state is associated with reduced lean body mass, and together with elevated circulating free fatty acids may increase the occurrence of lipotoxicity and insulin resistance. Thus, increased fat deposition is associated with a poor prognosis in OSA and COPD patients and therefore it is of clinical and scientific importance to understand the changes in fat metabolism and digestion as a result of OSA and COPD.
It is therefore our hypothesis that fat synthesis and insulin resistance is increased and whole body protein synthesis is decreased in OSA and COPD patients, leading to a poor prognosis.
Read the detailed description
This research study involves 3 visits for subjects and healthy controls. The first visit is the screening visit and includes review of the informed consent and a DXA scan and the second and third visit for the study days. For the first test day, 3 hours of the subjects time will be for urine and blood sample collection, and to stable isotope administration (deuterated water, isotopically labeled amino acids). Subjects are allowed to go home after and eat normally. On the second study day, subjects will arrive early that morning. For the duration of the study, subjects have to lie in the bed (except for bathroom privileges). They can watch tv or bring and use a book/tablet. The research nurse or study staff will be present in the human subject area to assist the subject if necessary. Subjects are not allowed to eat or drink during the second test day, except for the test drink (meal) and water. One IV catheter will be placed in a vein of the arm/hand for blood draws. The hand will be placed in a hot box during blood collection. Another IV catheter will be placed in the contra-lateral forearm for a primed and continuous infusion of isotopes (isotopically labeled amino acids and glycerol). Each day, a total of 80-100 ml of blood will be obtained. Stable isotopes will be ingested and infused on the first test day and added to the test drinks and infused on the second day. On the second test day, subjects will fill out questionnaires. After completion of the study, we will provide the subject with a meal.
- Keywords
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Obesity, Hepatic fat metabolism, fat digestion, whole body protein synthesis, protein digestion, amino acid metabolism, adipose tissue fat metabolism, lipolysis
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD and OSA | Subjects with diagnosis of COPD and OSA | |
| COPD | Subjects with diagnosis of COPD | |
| OSA | Subjects with diagnosis of OSA | |
| controls | Gender, age, BMI matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic triglyceride synthesis
changes in hepatic triglyceride synthesis before and after a meal
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Hepatic de novo lipogenesis
changes in hepatic de novo lipogenesis before and after a meal
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Adipose tissue triglyceride synthesis
changes in adipose tissue triglyceride synthesis before and after a meal
Measured: pre and 4 hours post meal
Adipose tissue de novo lipogenesis
changes in adipose tissue de novo lipogenesis before and after a meal
Measured: pre and 4 hours post meal
Adipose tissue lipolysis - glycerol rate of appearance
changes in adipose tissue lipolysis before and after a meal. plasma enrichment of glycerol.
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Rate of appearance of ingested glucose
determine changes in appearance of glucose rate in subjects
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Endogenous Glucose Production
Determine whole body glucose production in subjects
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Glucose disposal
Determine whole body glucose uptake in subjects
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Net whole-body protein synthesis
change in whole-body protein synthesis rate after intake of meal
Measured: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Citrulline Rate of appearance
plasma enrichment of citrulline
Measured: Postabsorptive state during 2 hours
Arginine turnover rate
Arginine enrichment in plasma
Measured: postabsorptive state during 3 hours
Whole body collagen breakdown rate
Hydroxyproline enrichment in plasma
Measured: Postabsorptive state during 3 hours
Tryptophan turnover rate
Tryptophan enrichment in plasma
Measured: Postabsorptive state during 3 hours
Myofibrillar protein breakdown rate
3methylhistidine enrichment in plasma
Measured: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Glycine rate of appearance
glycine enrichment in plasma
Measured: Postabsorptive state during 3 hours
Taurine turnover rate
enrichment of taurine in
Measured: postabsorptive state during 3 hours
Secondary outcomes (5)
Fat digestion and absorption
defining fat digestion and absorption after a meal. Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Insulin response to feeding
acute changes from postabsorptive state to postprandial state
Measured: pre and up to 5 hours post meal
Body composition
body composition will be determined by dual-energy X-ray absorptiometry and by deuterated water dilution technique. Plasma deuterium enrichments will be determined.
Measured: 1 day
Physical activity questionnaire
Outcome of physical activity assessment in breast cancer patients and healthy controls in relation to the fat metabolism
Measured: 1 day
Protein digestion after feeding
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Measured: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Ph.D., Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157844
- Sponsor's protocol ID
- 2013-0878F
- Status last verified
- Feb 2022
- First submitted
- 4 Jun 2014
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
PubMed 39423760Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.
PubMed 38616018Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
PubMed 37542951
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Metabolism and Digestion in Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02157844
- Acronym / sponsor ID
- 2013-0878F
- Keywords
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Obesity, Hepatic fat metabolism, fat digestion, whole body protein synthesis, protein digestion, amino acid metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Jun 2014 (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.
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia and re-oxygenation, which lead to increased oxidative stress, increased inflammation, endothelial dysfunction, and insulin resistance. Chronic obstructive pulmonary disease (COPD) is a lung disease that leads to poor airflow. This disease leads to systemic hypoxia, reduced oxidative capacity, and increased inflammation. The direct cause of OSA and COPD is unclear, but OSA and COPD may be linked to other comorbid conditions such as obesity and type II diabetes. Upon onset of OSA and COPD, metabolic disturbances associated with obesity and type II diabetes can be exacerbated.
Obesity is a condition characterized by an increase in visceral fat, elevated plasma levels of free fatty acids, inflammation, and insulin resistance. Although the effects of body fat distribution have not been studied in these patients, an increase in both subcutaneous and abdominal fat mass in non-OSA older women was shown to increase morbidity and mortality. Fat/adipose tissue is an active tissue capable of secreting proinflammatory cytokines such as tumor necrosis factor (TNF)-alpha and interleukin (IL)-6, reactive oxygen species and adipokines. Particularly, abdominal fat is a prominent source of pro-inflammatory cytokines, which contributes to a low grade, chronic inflammatory state in these patients. Additionally, an increased inflammatory state is associated with reduced lean body mass, and together with elevated circulating free fatty acids may increase the occurrence of lipotoxicity and insulin resistance. Thus, increased fat deposition is associated with a poor prognosis in OSA and COPD patients and therefore it is of clinical and scientific importance to understand the changes in fat metabolism and digestion as a result of OSA and COPD.
It is therefore our hypothesis that fat synthesis and insulin resistance is increased and whole body protein synthesis is decreased in OSA and COPD patients, leading to a poor prognosis.
Detailed description
This research study involves 3 visits for subjects and healthy controls. The first visit is the screening visit and includes review of the informed consent and a DXA scan and the second and third visit for the study days. For the first test day, 3 hours of the subjects time will be for urine and blood sample collection, and to stable isotope administration (deuterated water, isotopically labeled amino acids). Subjects are allowed to go home after and eat normally. On the second study day, subjects will arrive early that morning. For the duration of the study, subjects have to lie in the bed (except for bathroom privileges). They can watch tv or bring and use a book/tablet. The research nurse or study staff will be present in the human subject area to assist the subject if necessary. Subjects are not allowed to eat or drink during the second test day, except for the test drink (meal) and water. One IV catheter will be placed in a vein of the arm/hand for blood draws. The hand will be placed in a hot box during blood collection. Another IV catheter will be placed in the contra-lateral forearm for a primed and continuous infusion of isotopes (isotopically labeled amino acids and glycerol). Each day, a total of 80-100 ml of blood will be obtained. Stable isotopes will be ingested and infused on the first test day and added to the test drinks and infused on the second day. On the second test day, subjects will fill out questionnaires. After completion of the study, we will provide the subject with a meal.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COPD and OSA | – | –Subjects with diagnosis of COPD and OSA |
| COPD | – | –Subjects with diagnosis of COPD |
| OSA | – | –Subjects with diagnosis of OSA |
| controls | – | –Gender, age, BMI matched controls |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with OSA or COPD will be recruited when visiting a medical or pulmonary clinic in and outside the surrounding area of College Station. Patients and healthy subjects will also be recruited by responding to distributed flyers in the community in the College Station area; for example in hospital/clinic waiting areas, clinic rooms and bulletin boards at Scott \& White and the CSMC or any other hospital. Other general recruitment material in relation to the nutrition research that the research group performs at Texas A\&M can be placed on bulletin boards at Scott \& White and the CSMC.
Key inclusion criteria (14 listed)
- Established diagnosis of OSA or COPD
- Ability to sign informed consent
- Ability to walk, sit down and stand up independently
- Age 30 years and older
- Ability to lie in supine position for up to 8 hours
Key exclusion criteria (13 listed)
- Established diagnosis of malignancy
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatic triglyceride synthesis
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
changes in hepatic triglyceride synthesis before and after a meal
Hepatic de novo lipogenesis
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
changes in hepatic de novo lipogenesis before and after a meal
Adipose tissue triglyceride synthesis
Time frame: pre and 4 hours post meal
changes in adipose tissue triglyceride synthesis before and after a meal
Adipose tissue de novo lipogenesis
Time frame: pre and 4 hours post meal
changes in adipose tissue de novo lipogenesis before and after a meal
Adipose tissue lipolysis - glycerol rate of appearance
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
changes in adipose tissue lipolysis before and after a meal. plasma enrichment of glycerol.
Rate of appearance of ingested glucose
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
determine changes in appearance of glucose rate in subjects
Endogenous Glucose Production
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Determine whole body glucose production in subjects
Glucose disposal
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Determine whole body glucose uptake in subjects
Net whole-body protein synthesis
Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
change in whole-body protein synthesis rate after intake of meal
Citrulline Rate of appearance
Time frame: Postabsorptive state during 2 hours
plasma enrichment of citrulline
Arginine turnover rate
Time frame: postabsorptive state during 3 hours
Arginine enrichment in plasma
Whole body collagen breakdown rate
Time frame: Postabsorptive state during 3 hours
Hydroxyproline enrichment in plasma
Tryptophan turnover rate
Time frame: Postabsorptive state during 3 hours
Tryptophan enrichment in plasma
Myofibrillar protein breakdown rate
Time frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
3methylhistidine enrichment in plasma
Glycine rate of appearance
Time frame: Postabsorptive state during 3 hours
glycine enrichment in plasma
Taurine turnover rate
Time frame: postabsorptive state during 3 hours
enrichment of taurine in
5 secondary outcomes
Fat digestion and absorption
Time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Insulin response to feeding
Time frame: pre and up to 5 hours post meal
Body composition
Time frame: 1 day
Physical activity questionnaire
Time frame: 1 day
Protein digestion after feeding
Time frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
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 4 Feb 2022.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Derived from this study: PubMed 39423760Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
- Derived from this study: PubMed 38616018Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.
- Derived from this study: PubMed 37542951Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
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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.
Marielle Engelen, Ph.D. principal investigator
Texas A&M University
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 Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by Texas A&M University 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 14 inclusion and 13 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 4 Feb 2022. 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?
Hepatic triglyceride synthesis (time frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion). The study lists 16 primary outcomes in all. 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 NCT02157844, which also lists 4 linked publications.
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 4 Feb 2022.