Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01793766
Eligibility Criteria:
Inclusion Criteria:
1. Men and women age 20-55 years old
2. BMI 30-50 kg/m2
3. Willing to undergo 10 week supervised VLCD
Exclusion Criteria:
1. Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
2. Subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs
3. Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
4. Hemoglobin \<10 g/dL, Creatinine \>1.5 mg/dL
5. QT interval \>440 ms on EKG
6. Subjects with unstable psychiatric conditions as assessed by a psychologist
7. Allergy or intolerance to components of the mixed meal challenge
8. Additional contraindications to receive transcranial direct current stimulation (tDCS):
1. Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
2. Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
3. Prior neurosurgical procedure or radiation treatment to the brain.
4. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
5. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt or any metallic implant on the head.
(Note: Intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tDCS.)
9. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
10. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01793766
Study Brief:
Protocol Section:
NCT01793766