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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine and B12 | Drug |
|
| |
| Phentermine |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Weight change from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention (phentermine and B12) and control (phentermine) groups. | 24 weeks (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Blood pressure changes from baseline to 6 weeks, 12 weeks, and 24 weeks among the intervention and control groups. | 24 weeks |
| Waist Circumference | Changes in waist circumference from baseline to 12 weeks and 24 weeks among the intervention and control groups. |
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Individuals can participate in the study if they meet the following inclusion criteria:
Individuals should not participate in if any of the following apply to them:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Lang, MD | ECU Physicians General Internal Medicine, Psychiatry | Principal Investigator |
| James Powell, MD | ECU Physicians General Internal Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brody Outpatient of Brody Medical Sciences Module D | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Drug |
|
|
| 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. | 24 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Organic Chemicals |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |