ObesityEarly Phase 1NCT01719185
The Effect of Phentermine and B12 on Weight Loss Among Obese Patients
A Early Phase 1 study testing Phentermine and B12 and Phentermine in people with Obesity and Hypertension, run by Dr. Michael Lang at 1 site in United States.
Trial summary
This is a pilot study designed to test the hypothesis that the combination of phentermine and B12 will result in significantly greater weight loss among obese patients compared to phentermine alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Phentermine and B12 and Phentermine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2013
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Individuals can participate in the study if they meet the following inclusion criteria:
- Are over the age of 18
- Have a BMI between 30 and 40
- Have a controlled blood pressure
- Do not have a B12 deficiency
- Are willing to take birth control (if female and not sterile or through menopause)
- Are English speaking
Individuals should not participate in if any of the following apply to them:
- Are not over the age of 18
- Do not have a BMI between 30 and 40
- Do not have a controlled blood pressure
- Have a B12 deficiency
- Females who are pregnant, trying to get pregnant, or not willing to use a method of birth control to ensure they do not become pregnant
- Individuals who do not speak English
- Individuals currently taking Adderall, Ritalin, or any other stimulant medication
- Individuals who have taken phentermine more than once in the past, or within 3 months of study initiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Brody Outpatient of Brody Medical Sciences Module D
Greenville, North Carolina, 27834
About this study
Official title: A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population
This is a pilot study designed to test the hypothesis that the combination of phentermine and B12 will result in significantly greater weight loss among obese patients compared to phentermine alone.
Read the detailed description
This pilot study is a double blind, randomized controlled trial designed to determine the significance of the combination therapy of phentermine and B12 injections among the obese population. The study population will be recruited from the ECU Physicians Internal Medicine clinic. Physicians will select patients meeting inclusion and exclusion criteria from their clinic to be approached for recruitment. Approximately 30 patients will be recruited and blindly randomized to either the treatment group (phentermine and B12 in combination) or the control group (phentermine alone). Patients will be randomized by means of block randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group assignments through the entire duration of the study. Once randomized, both groups will begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections of either 1000 mg B12 or Saline depending on their group assignment. The study will consist of approximately 15 visits over the course of 3 months.
- Conditions
- Obesity, Hypertension
- Being tested
- Phentermine and B12, Phentermine
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentermine and B12Drug
Also called Adipex-P, Cyanocobalamin
PhentermineDrug
Also called Adipex- P
| Study group | Role | What they receive |
|---|---|---|
| Phentermine and B12 | Experimental | Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly. Receives: Drug: Phentermine and B12 |
| Phentermine | Active comparator | Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly. Receives: Drug: Phentermine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.
Measured: 24 weeks (6 months)
Secondary outcomes (3)
Blood Pressure
Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups.
Measured: 24 weeks
Waist Circumference
Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups.
Measured: 24 weeks
Waist to hip ratio
Changes in waist to hip ratio from baseline to 12 weeks and 24 weeks among the intervention and control group.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionApr 2013
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Lang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Michael Lang, East Carolina University
- Investigators
- Michael C Lang, MD, Principal investigator, ECU Physicians General Internal Medicine, PsychiatryJames Powell, MD, Study chair, ECU Physicians General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719185
- Sponsor's protocol ID
- 12-001323
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2012
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Whether the Combination of Phentermine and B12 Has a Significant Effect on Weight Loss Among an Obese Study Population
- ClinicalTrials.gov ID
- NCT01719185
- Acronym / sponsor ID
- 12-001323
- Conditions
- Obesity, Hypertension
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dr. Michael LangUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Nov 2012 (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.
This is a pilot study designed to test the hypothesis that the combination of phentermine and B12 will result in significantly greater weight loss among obese patients compared to phentermine alone.
Detailed description
This pilot study is a double blind, randomized controlled trial designed to determine the significance of the combination therapy of phentermine and B12 injections among the obese population. The study population will be recruited from the ECU Physicians Internal Medicine clinic. Physicians will select patients meeting inclusion and exclusion criteria from their clinic to be approached for recruitment. Approximately 30 patients will be recruited and blindly randomized to either the treatment group (phentermine and B12 in combination) or the control group (phentermine alone). Patients will be randomized by means of block randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group assignments through the entire duration of the study. Once randomized, both groups will begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections of either 1000 mg B12 or Saline depending on their group assignment. The study will consist of approximately 15 visits over the course of 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phentermine and B12 | Experimental | Drug: Phentermine and B12Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly. |
| Phentermine | Active comparator | Drug: PhentermineThose in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Phentermine and B12Also: Adipex-P, Cyanocobalamin | Drug | Phentermine and B12 |
| PhentermineAlso: Adipex- P | Drug | Phentermine |
Primary outcome
Weight Change
Time frame: 24 weeks (6 months)
Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups.
3 secondary outcomes
Blood Pressure
Time frame: 24 weeks
Waist Circumference
Time frame: 24 weeks
Waist to hip ratio
Time frame: 24 weeks
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 13 Aug 2015.
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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.
Michael C Lang, MD principal investigator
ECU Physicians General Internal Medicine, Psychiatry
James Powell, MD study chair
ECU Physicians General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phentermine and B12 and Phentermine in people with Obesity and Hypertension, run by Dr. Michael Lang 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?
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 13 Aug 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Weight Change (time frame: 24 weeks (6 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 13 Aug 2015.