ObesityNCT00691158
A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide
A study testing Pramlintide (Amylin), 2 Metreleptin and Leptin plus Pramlintide 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 help control body weight respond to an infusion of hormones called leptin and amylin. 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?
- Pramlintide (Amylin), 2 Metreleptin and Leptin plus Pramlintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2024
- Phase
- Interventional
- 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
- MI 18 to 25 kg/m2 or ≥ 30 kg/m2
- 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
- seizure disorder.
Show all 19Show fewer
- Exercise > 30 minutes, 3 times a week
- Alcohol consumption > 2 drinks / day
- Weight > 350 lbs (159 kg) (weight limit for MR machine)
- Illicit drug use
- Pregnancy
- Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate 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
- Anaphylaxis and known hypersensitivity to E. coli-derived proteins
- Allergies or contraindications to metreleptin or pramlintide
- Renal or hepatic impairment
- Women who are lactating
- Tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Pilot Study of the fMRI Response to Leptin and Pramlintide
The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.
Read the detailed description
Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.
- Conditions
- Obesity
- Being tested
- Pramlintide (Amylin), Placebo (Normal Saline), 2 Metreleptin, Leptin plus Pramlintide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramlintide (Amylin)Drug
Also called Amylin
4.7 mls of Amylin 15mcg/ml IV bolus.
Placebo (Normal Saline)Drug
Also called Placebo
4.7 mls normal saline IV bolus x1
2 MetreleptinDrug
Also called Leptin
Receive .06mg/kg of metreleptin IV bolus x1
Leptin plus PramlintideDrug
Also called Leptin and Amylin
receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1- Normal Saline | Placebo comparator | 4.7 mls normal saline IV bolus Receives: Drug: Placebo (Normal Saline) |
| 2 Metreleptin | Active comparator | IV Leptin bolus Receives: Drug: 2 Metreleptin |
| 3 Pramlintide | Active comparator | IV Pramlintide bolus at Timpoint +0 and +30 minutes Receives: Drug: Pramlintide (Amylin) |
| 4 Leptin plus Pramlintide | Active comparator | leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes Receives: Drug: Leptin plus Pramlintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.
measurements at each study time are include fMRI, blood draws and Visual Analog Score.
Measured: over 90 minutes
Secondary outcomes (1)
Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.
Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90
Measured: over 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
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.
- More trials run by Oregon Health and Science UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
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, OHSU - Center for the Study of Weight Regulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691158
- Sponsor's protocol ID
- eIRB #2168
- Other IDs
- OCTRI #933
- Status last verified
- Dec 2022
- First submitted
- 2 Jun 2008
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the fMRI Response to Leptin and Pramlintide
- ClinicalTrials.gov ID
- NCT00691158
- Acronym / sponsor ID
- eIRB #2168
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Jun 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 help control body weight respond to an infusion of hormones called leptin and amylin.
Detailed description
Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1- Normal Saline | Placebo comparator | Drug: Placebo (Normal Saline)4.7 mls normal saline IV bolus |
| 2 Metreleptin | Active comparator | Drug: 2 MetreleptinIV Leptin bolus |
| 3 Pramlintide | Active comparator | Drug: Pramlintide (Amylin)IV Pramlintide bolus at Timpoint +0 and +30 minutes |
| 4 Leptin plus Pramlintide | Active comparator | Drug: Leptin plus Pramlintideleptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes |
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
- MI 18 to 25 kg/m2 or ≥ 30 kg/m2
- At maximal lifetime weight
- Weight stable for at least 3 months
Key exclusion criteria (19 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:
- Exercise > 30 minutes, 3 times a week
- Alcohol consumption > 2 drinks / day
- Weight > 350 lbs (159 kg) (weight limit for MR machine)
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 |
|---|---|---|
| Pramlintide (Amylin)Also: Amylin4.7 mls of Amylin 15mcg/ml IV bolus. | Drug | 3 Pramlintide |
| Placebo (Normal Saline)Also: Placebo4.7 mls normal saline IV bolus x1 | Drug | 1- Normal Saline |
| 2 MetreleptinAlso: LeptinReceive .06mg/kg of metreleptin IV bolus x1 | Drug | 2 Metreleptin |
| Leptin plus PramlintideAlso: Leptin and Amylinreceive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes. | Drug | 4 Leptin plus Pramlintide |
Primary outcome
To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.
Time frame: over 90 minutes
measurements at each study time are include fMRI, blood draws and Visual Analog Score.
1 secondary outcome
Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.
Time frame: over 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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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
OHSU - Center for the Study of Weight Regulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pramlintide (Amylin), 2 Metreleptin and Leptin plus Pramlintide 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 19 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: status not confirmed, as of the sponsor's last update on 16 Dec 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. 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.
Are results available for this study?
Results are not available in the source record.
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?
To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control. (time frame: over 90 minutes). 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 16 Dec 2022.