Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
Brief Summary: The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.


Options:
A: Inclusion Criteria:

* Age ≥ 10 and ≤ 16 years at study entry
* Caucasian descent
* Obesity defined as BMI-SDS \> 2.3
* Insulin resistance defined as HOMA-IR ≥ 3.4.
* An obtained informed consent from subjects and parents/caregivers.

Exclusion Criteria:

* Presence of T2DM (American Diabetes Association criteria)
* Presence of endocrine disorders with steroid therapy
* Suspicion of polycystic ovarium syndrome;
* Height \< -1.3 SD of target height;
* Syndrome disorders with or without mental retardation;
* Use of anti-hyperglycaemic drugs;
* Pregnancy (pregnancy test will be performed, if applicable);
* (History of) alcohol abuse;
* Impaired renal and/or hepatic function (defined as GFR \< 80 ml/min. GFR=40 x length (cm) / serumcreatinin (μmol/l and ALAT \>150% of normal value for age);
* Use of ritonavir; use of ACE inhibitors;
* Insufficient knowledge of the Dutch language.
B: Inclusion Criteria:

* You are healthy.
* You are not pregnant or nursing.
* You are between 18 and 60 years of age.
* You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.

Exclusion Criteria:

* You take chronic medications except hormone replacement or contraception.
* You are a woman and are unwilling to use effective contraception during the trial.
* You have blood pressure higher than 150/90.
* You have heart disease.
* You have urinary symptoms from an enlarged prostate.
* You have gained or lost more than 10 pounds in the last 6 months.
* You have used a monoamine oxidase inhibitor medication in the last month.
* You have high or low thyroid function that has not been controlled in the normal range for at least 2 months.
* You have heart disease or a history of stroke.
* You have a known sensitivity to E. coli or E. coli derived products.
C: * INCLUSION CRITERIA:

Volunteers will qualify for participation in the study if they meet the following criteria:

1. \<TAB\>Age 13-17 years.
2. \<TAB\>Good general health as indicated by medical history and physical examination.
3. \<TAB\>Negative urine glucose and normal electrolytes, hepatic, and thyroid function.
4. \<TAB\>For the fMRI portion only: right handedness (required for standardization of responses).
5. \<TAB\>For the fMRI portion only: female.
6. \<TAB\>For the fMRI portion only: overweight (BMI greater than or equal to 85th percentile for age and sex).

EXCLUSION CRITERIA:

Volunteers will be excluded if they have any of the following:

1. \<TAB\>Medical problem likely to affect caloric intake.
2. \<TAB\>History of any condition including psychiatric disorders in either child or their responsible parent that in the opinion of the investigators would impede competence to sign consent, interfere with adherence to procedures, or possibly hinder completion of the study.
3. \<TAB\>Pregnancy.
4. \<TAB\>Use of medication likely to affect caloric intake.
5. \<TAB\>History of significant neurological injury or insult.
6. \<TAB\>For the fMRI portion only: braces (or other metal) that would interfere with the fMRI procedure.
7. \<TAB\>For the fMRI portion only: non-native English speakers (required for standardization of responses).
D: Inclusion Criteria:

* Subject's body mass index (BMI) was \>= 27 kg/m(2) and \<= 45 kg/m(2) or their BMI was \>= 25 kg/m(2) and \< 27 kg/m(2) with waist circumference of \>= 102 cm in males or \>= 88 cm in females.
* Medical history positive for:

  * Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
  * Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)

Exclusion Criteria:

* History of recent myocardial infarction.
* Heart failure symptoms greater than New York Heart Association Functional Class II.
* Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
* Subjects without a pacemaker and with any of the following:

  * Sinus bradycardia (\< 50 bpm)
  * Sick sinus syndrome
  * Atrioventricular block of more than 1st degree
* Mean sitting systolic blood pressure (SBP) \> 160 mmHg. Mean sitting diastolic blood pressure (DBP) \> 100 mmHg. Mean sitting heart rate (HR) \> 100 bpm.
* Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
* Planned cardiac surgery or coronary angioplasty within 6 months of screening.
* History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
* Hyperthyroidism.
* Known chronic liver disease or endstage renal disease.
* Severe, symptomatic benign prostatic hyperplasia which may require surgery.
* Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
* Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
* Treated hypertension stabilized for less than 3 months.
* Inability to perform regular physical activity.

Answer: B