Please select the eligibility criteria that correspond to the clinical trial below.
Title: Endocrine Studies of Healthy Children
Brief Summary: Researchers would like to determine normal ranges for hormone levels and to learn more about the genetics involved in hormone production and action. Researchers will take samples of blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different aspects of hormones.

Establishing a range of normal hormone levels in children will make diagnosing illnesses with abnormal levels of hormones much easier. Hormone levels in the body can change throughout the day. By collecting samples at different times researchers hope to learn more about the normal daytime and nighttime patterns of hormone secretion. Because some hormone levels change with body size, researchers will also take measurements of patient's body composition.

This study will involve children and observe them as inpatients or as outpatients. \<TAB\>


Options:
A: Inclusion Criteria:

* Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
* Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
* BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
* Expressed desire for weight maintenance
* Accustomed to 3 main meals per day
* Commitment to avoid the use of other weight loss products during study
* Females' agreement to use appropriate birth control methods during the active study period
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
* History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
* History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
* Clinically relevant excursions of safety parameter
* Current use of anti-depressants
* Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
* Uncontrolled hypertension (more than 160/110 mm Hg)
* Stenosis in the GI tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to enrollment
* History of eating disorders like bulimia, anorexia nervosa within the past 12 months
* Other serious organ or systemic diseases such as cancer
* Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
* More than 3 hours strenuous sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within 6 months prior to enrolment
* Inability to comply due to language difficulties
* Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
B: Inclusion Criteria:

* Age 8-19 years old
* Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
* Body mass index (BMI) ≥ 99th percentile (based on gender and age)

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Initiation of a new drug therapy within the past 30 days prior to the screening visit
* BMI ≥ 55
* History of weight loss surgery
* Obesity from a genetic cause (e.g., Prader-Willi)
* Central nervous system injury or severe neurological impairment
* Known systolic or diastolic dysfunction or heart failure
* Females who are currently pregnant or planning to become pregnant
* Liver enzymes \> 2.5 times upper limit of normal
* Severe renal impairment (defined as creatinine clearance \<30 mL/min)
* Gastrointestinal disease
C: * INCLUSION CRITERIA:

Good general health.

Age 2 to 18 years.

EXCLUSION CRITERIA:

Volunteers will be excluded for the following reasons:

Presence of renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing's syndrome) or pulmonary disorders (other than asthma not requiring continuous medication);

Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study;

Subjects who regularly use prescription medications are not eligible. The use of over-the-counter medications will be reviewed on a case-by-case basis;

For those sub-studies involving MRI, inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications).
D: * INCLUSION CRITERIA:

Good general health. Individuals taking medications for obesity-related comorbid conditions will not be excluded.

Obesity: body mass index for age and triceps skinfold above the 95th percentile (determined by NHANES I age-, sex-, and race- specific data). All subjects will be required to be over 60 kg in body weight.

Evidence for a quantifiable obesity-related comorbidity. Examples include: systolic or diastolic hypertension (determined by age-specific charts); frank Type 2 diabetes, impaired glucose tolerance assessed by oral glucose tolerance testing; hyperinsulinemia (defined as a fasting insulin greater than 15 mIU/mL); significant hyperlipidemia (total cholesterol greater than 200 mg/dL, LDL cholesterol greater than 129 mg/dL or fasting triglycerides greater than 200 mg/dL); hepatic steatosis (SGPT or SGOT above normal range with negative hepatitis studies) or sleep apnea documented by a sleep study.

Age 12 to 17 years at the start of the study.

For girls with childbearing potential, a negative pregnancy test before taking and while taking study medication. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.

Race of all four grandparents self-identified as either all Caucasian or all African American.

EXCLUSION CRITERIA:

Volunteers will be excluded (and referred to non-experimental treatment programs) for the following reasons:

Presence of renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (other than either asthma not requiring continuous medication or sleep apnea-related disorders);

Adolescent girls who are pregnant, who are currently nursing an infant, or who are having unprotected intercourse;

Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study;

Subjects who regularly use prescription medications unrelated to the complications of obesity. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible;

Recent use (within six months) of anorexiant medications for the purpose of weight reduction;

Inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications).

For pilot study participants, hypersensitivity or allergy to methylene blue. Individuals with documented G6PD deficiency will be excluded.

INCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:

Volunteers will qualify for inclusion if they meet the following criteria:

1. Good general health.
2. Age 12-17 years at study entry.
3. Body mass index (BMI) for age above the 5th percentile and below 85th percentile, which is considered normal weight by CDC growth chart standards.
4. For females with childbearing potential, a negative pregnancy test at initial evaluation.
5. Race of all four grandparents self-identified as either all Caucasian or all African American.

EXCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:

Volunteers will be excluded for the following reasons:

1. Presence of past or present medical problems which would impair performance during the exercise tests;
2. Females who are pregnant, or who are currently nursing an infant;
3. Individuals who have, or whose parent or guardian has, current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or possibly hinder completion of the study;
4. Recent weight change of more than 3% of body weight in the past two months;
5. Recent use (within six months) of anorexiant medications for the purpose of weight reduction;
6. Physical impairments that would prevent completion of either the walk/run test or the cycle test.

Answer: C