ObesityPhase 2NCT00686608
Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients
A Phase 2 study testing glucose, fructose and saline in people with Obesity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- glucose, fructose and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2006to 1 Jul 2015
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 year to 45 years of age
- BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
- At maximal lifetime weight.
- Weight stable for at least 3 months.
Who cannot join
- Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
- Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
- Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
- Weight > 350 lbs or girth > 60 inches (the limits of the MR machine)
- Exercise > 30 minutes, 3 times a week.
- Alcohol consumption > 2 drinks / day.
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- Weight > 300 lbs (150 kg) (weight limit for MR machine).
- Blood glucose > 100 mg/dL, abnormal creatinine or liver function tests.
- Illicit drug use.
- Pregnancy.
- Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, or fat intakes.
- Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips.
- Those with claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Hypothalamic fMRI Response to Nutrients
The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.
Read the detailed description
To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.
- Conditions
- Obesity
- Being tested
- glucose, fructose, saline
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucoseDietary supplement
0.3mg/kg of glucose
fructoseDietary supplement
fructose IV bolus
salineDietary supplement
IV saline
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Experimental | IV glucose Receives: Dietary Supplement: glucose |
| Fructose | Active comparator | Not described Receives: Dietary Supplement: fructose |
| Saline | Placebo comparator | Not described Receives: Dietary Supplement: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.
Measured: 0,1,2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study start1 Oct 2006
- Primary completion1 Jul 2012
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive infusions of glucose, fructose, and saline in a randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Purnell, Oregon Health and Science University
- Investigators
- Jonathan Q. Purnell, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686608
- Sponsor's protocol ID
- eIRB #938
- Other IDs
- 791
- Status last verified
- Aug 2019
- First submitted
- 28 May 2008
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothalamic fMRI Response to Nutrients
- ClinicalTrials.gov ID
- NCT00686608
- Acronym / sponsor ID
- eIRB #938
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 30 May 2008 (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.
The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.
Detailed description
To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will receive infusions of glucose, fructose, and saline in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Glucose | Experimental | Dietary Supplement: glucoseIV glucose |
| Fructose | Active comparator | Dietary Supplement: fructose |
| Saline | Placebo comparator | Dietary Supplement: saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 year to 45 years of age
- BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
- At maximal lifetime weight.
- Weight stable for at least 3 months.
Key exclusion criteria (13 listed)
- Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
- Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
- Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
- Weight > 350 lbs or girth > 60 inches (the limits of the MR machine)
- Exercise > 30 minutes, 3 times a week.
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 |
|---|---|---|
| glucose0.3mg/kg of glucose | Dietary supplement | Glucose |
| fructosefructose IV bolus | Dietary supplement | Fructose |
| salineIV saline | Dietary supplement | Saline |
Primary outcome
The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.
Time frame: 0,1,2 and 3 months
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 7 Aug 2019.
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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.
Jonathan Q. Purnell, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucose, fructose and saline in people with Obesity, run by Oregon Health and Science 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 4 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 7 Aug 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately. (time frame: 0,1,2 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2019.