Heart Obesity Prevention Education

Completed · Not applicable

Conditions studied: Obesity

In brief

Study to collect data on weight management on a male population of retired NFL athletes.

Key facts

Study ID

NCT02092545

Run by

Tampa General Hospital

People needed

7

Starts

2014-05-01

Expected to finish

2014-12-01

Last updated by the study team

2014-12-19

Who can join

Age: 25 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males
• Former NFL players
• Aged 25-64 (Age range is chosen to keep participants as uniform as possible given the small number of participants. The majority of the players are in this age range and participants need to be able to exercise and be active. Also the NFL in its current form was created in 1970 so there are very few players that are retired from the NFL that are over the age of 65.)
• BMI >27
• English- speaking

You may not qualify if…

• Cancer within the last 5 years (except non-melanoma skin cancer)
• Significant Cardiovascular Disease (recent < 1 year Myocardial Infarction, hospital admission < 1year for Congestive Heart Failure, Active Angina, exercise induced Angina)
• Malignant arrhythmias (VTACH, AFIB, Aflutter)
• Renal Disease ( Dialysis or Chronic Renal Insufficiency)
• Hepatic Disease ( Hepatitis B and C or Liver function test 2.5 times the upper limits of normal, or liver transplant that requires immune odulating/suppressing medications, ammonia lowering medications, or hepatic disease related to diet modification).
• Psychosis, Severe Anxiety, or Major Depression
• Significant migraines requiring abortive medication in the last year
• Significant Endocrine dysfunction ( Cushing's Syndrome )
• Uncontrolled Hypertension > 160/90
• Severe arthritis that significantly limits mobility
• Uncontrolled Hyper/Hypothyroidism
• Obesity Surgery in the past
• Weight loss of greater than 10% of the subjects body weight in the last year
• Recent history (within 1 year ) of Alcohol abuse, illegal Drug abuse
• Active pulmonary disease that requires daily corticosteroids, an oxygen requirement, or ventilation support for chronic disease management.
• Participants currently taking or having been taking within the last 3 months the following medication will be excluded.
• Appetite Suppressants (Phenterimine, Qsymia)
• Anti-obesity medications (Xenical/Meridia)
• Corticosteroids or > 1500 micrograms of inhaled steroids daily
• Raloxifene (Evista) or Temoxifene (HRT medications)
• Inappropriate use of Testosterone
• At the discretion of the investigator use of Psychiatric Medication, Sedative/Hypnotics, Benzodiazepines
• Detailed Disease and Lab Value Exclusion
• Active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (>2 weeks) immune modulating/suppressing medications.
• Active renal disease will be defined as any patient who is currently, or has a history requiring potassium phosphate lowering medication, protein restriction diet, or hemo/peritoneal dialysis

Where it is running

• Tampa General Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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