Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study

Korábbi kezelés

• Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial or plan to initiate therapy during the trial.
• Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 1 month prior to screening for this trial.
• Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
• Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
• Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
• ≥2 no-shows to recruitment clinic within the 6 months prior to screening.

Egyéb

• Language barrier, mental incapacity, unwillingness or inability to understand.
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.

• Age ≥ 35 years
• Able to provide informed consent
• Overweight or Obese (BMI ≥25 kg/m2)
• Prediabetes or Type 2 Diabetes:
  • Fasting glucose >100 mg/dl, or
  • Hb A1c >5.7%, or
  • Medical (i.e. pharmacologic) treatment for type 2 diabetes
• At least 1 additional cardiovascular risk factor (defined by Adult Treatment Panel III criteria2) including:
  • Hypertension (BP>130/80 or on medical therapy for hypertension)
  • Low HDL-cholesterol (<40 mg/dL in men and <50 mg/dL in women)
  • High triglycerides (>150 mg/dL or on treatment for hypertriglyceridemia)
  • Obstructive sleep apnea (clinical diagnosis)
  • Coronary artery disease (clinical diagnosis)
  • Congestive heart failure (clinical diagnosis)
  • Atrial fibrillation (clinical diagnosis)