Healthy VolunteersPhase 3NCT00706381
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)
A Phase 3 study testing Sincalide, Ursodiol and Fat Meal in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sincalide, Ursodiol and Fat Meal
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2008to 21 Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to18 years, male or female
- Written informed consent
Who cannot join
- Hypo- or hyperthyroidism (history or serum thyroid-stimulating hormone (TSH) greater than 5.0 or less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg (26) or receiving antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 27 Kg/m(2)
- Diabetes mellitus (fasting serum glucose greater than or equal to 126 mg/dL)
- Hyperlipidemia (serum total cholesterol greater than or equal to 240 mg/dL, triglycerides greater than or equal to 220 mg/dL, and/or use of antilipemic therapy)
Show all 20Show fewer
- Liver disease or ALT serum concentrations greater than 1.5 times the upper laboratory reference limit
- Hyperbilirubinemia (serum total bilirubin greater than 1.5 mg/dL)
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation)
- Anemia (Hemoglobin concentration less than or equal to 11.1 g/dL females, and 12.7 g/dL males)
- History of cholecystectomy or cholelithiasis (by ultrasound at screening).
- History of malabsorption, or food allergies/intolerances that would preclude participant from consuming foods required for study
- Claustrophobia
- History of illicit drug or alcohol abuse within the last 5 years; current use of illicit drugs (by history) or alcohol (CAGE greater than 3)
- Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study
- Current use of medications/dietary supplements/alternative therapies known to alter thyroid function, energy expenditure or bile acid secretion
- History of weight loss or weight gain of greater than 3 percent body weight over the past 2 months (self-reported)
- Pregnancy/breastfeeding/hormonal contraceptive use and childbirth within the last 6 months
- Perimenopausal (as self-described within two years from onset of amenorrhea or current complaints of hot flashes)
- Current smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate.
The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone.
Read more
This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids.
Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design.
The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.
Read the detailed description
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate.
The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone.
This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids.
Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design.
The following parameters will be recorded and compared to placebo:
Energy expenditure
Substrate utilization
Spontaneous movements
Skin and core temperature
Serial changes in circulating thyroid hormones
Serial changes in bile acid serum concentrations
The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.
- Conditions
- Healthy Volunteers
- Being tested
- Sincalide, Ursodiol, Fat Meal, Carb meal, Placebo
- Keywords
- Deiodinase, Bile Acids, Cholecystokinin, Thyroid Hormones, Energy Expenditure, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SincalideDrug
UrsodiolDrug
Fat MealProcedure or surgery
600 calorie meal containing 72% fat, 8% protein, and 20% carbohydrate
Carb mealProcedure or surgery
600 calorie meal containing 100% carbohydrate
PlaceboDrug
IV and/or oral placebo
| Study group | Role | What they receive |
|---|---|---|
| 1: Carb meal, fat meal, sincalide, placebo, urso | Experimental | Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5 Receives: Drug: Sincalide; Drug: Ursodiol; Procedure: Fat Meal; Procedure: Carb meal; Drug: Placebo |
| 2: Fat meal, carb meal, sincalide, placebo, urso | Experimental | Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5 Receives: Drug: Sincalide; Drug: Ursodiol; Procedure: Fat Meal; Procedure: Carb meal; Drug: Placebo |
| 3: Carb meal, fat meal, placebo, sincalide, urso | Experimental | Participants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5 Receives: Drug: Sincalide; Drug: Ursodiol; Procedure: Fat Meal; Procedure: Carb meal; Drug: Placebo |
| 4: Fat meal, carb meal, placebo, sincalide, urso | Experimental | Participants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5 Receives: Drug: Sincalide; Drug: Ursodiol; Procedure: Fat Meal; Procedure: Carb meal; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Expenditure
Energy expenditure is measured over 6 hours in a respiratory chamber for each intervention and placebo.
Measured: 6 hours
Bile Acid
Bile acid is measured at 0, 60, 90 and 360 minutes during a 6 hour stay in in a respiratory chamber for each intervention and placebo. The mean of these 4 values is then calculated.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study start23 Jun 2008
- Primary completion21 Aug 2012
- Study completion21 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kong Y Chen, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706381
- Sponsor's protocol ID
- 080165
- Other IDs
- 08-DK-0165
- Status last verified
- 4 Aug 2017
- First submitted
- 26 Jun 2008
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. doi: 10.1210/er.2006-0032. Epub 2006 Nov 22.
PubMed 17122359Rosen ED, Spiegelman BM. Adipocytes as regulators of energy balance and glucose homeostasis. Nature. 2006 Dec 14;444(7121):847-53. doi: 10.1038/nature05483.
PubMed 17167472Blaak EE, Hul G, Verdich C, Stich V, Martinez JA, Petersen M, Feskens EF, Patel K, Oppert JM, Barbe P, Toubro S, Polak J, Anderson I, Astrup A, Macdonald I, Langin D, Sorensen T, Saris WH; NUGENOB Consortium. Impaired fat-induced thermogenesis in obese subjects: the NUGENOB study. Obesity (Silver Spring). 2007 Mar;15(3):653-63. doi: 10.1038/oby.2007.606.
PubMed 17372316
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)
- ClinicalTrials.gov ID
- NCT00706381
- Acronym / sponsor ID
- 080165
- Conditions
- Healthy Volunteers
- Keywords
- Deiodinase, Bile Acids, Cholecystokinin, Thyroid Hormones, Energy Expenditure, Healthy Volunteer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 23 Jun 2008
- Primary completion
- 21 Aug 2012 (actual)
- Study completion
- 21 Aug 2012 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 22 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate.
The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone.
This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids.
Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design.
The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.
Detailed description
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are believed to differ according to the type of food consumed, whether fat, protein or carbohydrate.
The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a meal, play an important role in the absorption of fat and the management of cholesterol stores in the body. Recent studies suggest that BAs may also serve as regulators of energy expenditure (consumption) in the cells of our body by increasing the production of T3, an active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which our bodies burn calories thereby generating heat. Although this process has been shown to be effective in rodents who demonstrated weight loss after treatment, the role of BAs in humans is poorly understood. Thus we do not know whether endogenous (produced by the body) or exogenous (taken as medication) BAs play a significant role in the maintenance of body weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing energy expenditure via the production of the active form of thyroid hormone.
This randomized, cross-over study will look at changes in thyroid hormones and energy consumption in response to stimuli of endogenous BA secretion including dietary content, and to the intake of pharmacological doses of bile acids.
Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a 6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate intervention. During the following three days, the study subjects will again be randomized to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment of cholecystokinin) 0.04 mcg/kg or placebo and P.O. placebo, or I.V. placebo and 15 mg/kg of BA (ursodiol) with similar metabolic chamber stays and cross-over design.
The following parameters will be recorded and compared to placebo:
Energy expenditure
Substrate utilization
Spontaneous movements
Skin and core temperature
Serial changes in circulating thyroid hormones
Serial changes in bile acid serum concentrations
The data gathered from this study will provide greater insight into the physiological and molecular mechanism(s) regulating the relation between endogenous bile acid secretion and energy metabolism in response to meals, as well as the role of BAs per se on energy metabolism.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Carb meal, fat meal, sincalide, placebo, urso | Experimental | Drug: Sincalide, Drug: Ursodiol, Procedure: Fat Meal, Procedure: Carb meal, Drug: PlaceboParticipants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, and IV placebo + PO Ursodiol 15mg/kg day 5 |
| 2: Fat meal, carb meal, sincalide, placebo, urso | Experimental | Drug: Sincalide, Drug: Ursodiol, Procedure: Fat Meal, Procedure: Carb meal, Drug: PlaceboParticipants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV sincalide 0.04mcg/kg + PO placebo day 3, IV placebo + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5 |
| 3: Carb meal, fat meal, placebo, sincalide, urso | Experimental | Drug: Sincalide, Drug: Ursodiol, Procedure: Fat Meal, Procedure: Carb meal, Drug: PlaceboParticipants randomized to consume a 100% carbohydrate meal day 1, then a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, then IV placebo + PO Ursodiol 15mg/kg day 5 |
| 4: Fat meal, carb meal, placebo, sincalide, urso | Experimental | Drug: Sincalide, Drug: Ursodiol, Procedure: Fat Meal, Procedure: Carb meal, Drug: PlaceboParticipants randomized to consume a high fat (72% fat, 8% protein, 20% carbohydrate) meal day 1, then a 100% carbohydrate meal day 2, IV placebo + PO placebo day 3, IV sincalide 0.04mcg/kg + PO placebo day 4, the IV placebo + PO Ursodiol 15mg/kg day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to18 years, male or female
- Written informed consent
Key exclusion criteria (20 listed)
- Hypo- or hyperthyroidism (history or serum thyroid-stimulating hormone (TSH) greater than 5.0 or less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg (26) or receiving antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 27 Kg/m(2)
- Diabetes mellitus (fasting serum glucose greater than or equal to 126 mg/dL)
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 |
|---|---|---|
| Sincalide | Drug | 1: Carb meal, fat meal, sincalide, placebo, urso, 2: Fat meal, carb meal, sincalide, placebo, urso, 3: Carb meal, fat meal, placebo, sincalide, urso, 4: Fat meal, carb meal, placebo, sincalide, urso |
| Ursodiol | Drug | 1: Carb meal, fat meal, sincalide, placebo, urso, 2: Fat meal, carb meal, sincalide, placebo, urso, 3: Carb meal, fat meal, placebo, sincalide, urso, 4: Fat meal, carb meal, placebo, sincalide, urso |
| Fat Meal600 calorie meal containing 72% fat, 8% protein, and 20% carbohydrate | Procedure or surgery | 1: Carb meal, fat meal, sincalide, placebo, urso, 2: Fat meal, carb meal, sincalide, placebo, urso, 3: Carb meal, fat meal, placebo, sincalide, urso, 4: Fat meal, carb meal, placebo, sincalide, urso |
| Carb meal600 calorie meal containing 100% carbohydrate | Procedure or surgery | 1: Carb meal, fat meal, sincalide, placebo, urso, 2: Fat meal, carb meal, sincalide, placebo, urso, 3: Carb meal, fat meal, placebo, sincalide, urso, 4: Fat meal, carb meal, placebo, sincalide, urso |
| PlaceboIV and/or oral placebo | Drug | 1: Carb meal, fat meal, sincalide, placebo, urso, 2: Fat meal, carb meal, sincalide, placebo, urso, 3: Carb meal, fat meal, placebo, sincalide, urso, 4: Fat meal, carb meal, placebo, sincalide, urso |
Primary outcome
Energy Expenditure
Time frame: 6 hours
Energy expenditure is measured over 6 hours in a respiratory chamber for each intervention and placebo.
Bile Acid
Time frame: 6 hours
Bile acid is measured at 0, 60, 90 and 360 minutes during a 6 hour stay in in a respiratory chamber for each intervention and placebo. The mean of these 4 values is then calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17122359Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. doi: 10.1210/er.2006-0032. Epub 2006 Nov 22.
- Background: PubMed 17167472Rosen ED, Spiegelman BM. Adipocytes as regulators of energy balance and glucose homeostasis. Nature. 2006 Dec 14;444(7121):847-53. doi: 10.1038/nature05483.
- Background: PubMed 17372316Blaak EE, Hul G, Verdich C, Stich V, Martinez JA, Petersen M, Feskens EF, Patel K, Oppert JM, Barbe P, Toubro S, Polak J, Anderson I, Astrup A, Macdonald I, Langin D, Sorensen T, Saris WH; NUGENOB Consortium. Impaired fat-induced thermogenesis in obese subjects: the NUGENOB study. Obesity (Silver Spring). 2007 Mar;15(3):653-63. doi: 10.1038/oby.2007.606.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Kong Y Chen, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sincalide, Ursodiol and Fat Meal in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 20 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 22 Jul 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Energy Expenditure (time frame: 6 hours). The study lists 2 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 NCT00706381, which also lists 3 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 22 Jul 2020.