Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.

CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01008371

Enrollment

Registered

2009-11-05

Start date

2009-10-31

Completion date

2013-03-31

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Gastric Emptying, Obesity, Panic Disorder

Keywords

Obesity, Cholecystokinin, Oxytocin, Satiety, Gastric emptying, Anxiety, Depression, Panic Disorder

Brief summary

The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair the ability to feel full and which therefore, may lead to obesity.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Males and females 18 to 65 years of age. * Obese Subjects with BMI \>40. * Normal weight subjects with BMI = 18.5-24.9

Exclusion criteria

* Age younger than 18 years and over 65 years of age. * Current use of narcotics or morphine * Previous gastric surgery * Presence of the following disorders that are known to cause functional gastric stasis syndromes: Diabetes Mellitus, Hypothyroidism, Progressive Systemic Sclerosis, Systemic Lupus Erythematosus, Dermatomyositis, Familial Dysautonomia, Pernicious Anemia, Bulbar poliomyelitis, Amyloidosis, Gastric Ulcer, Post-vagotomy, Tumor-associated gastroparesis, Fabry disease, Myotonic Dystrophy, Post-operative ileus, Gastroenteritis. * Presence of the following disorders that are known to cause delayed gastric emptying: peptic ulceration, recent surgery, pyloric hypertrophy, post-radiotherapy, ileus, anorexia nervosa, acute viral infections. * Presence of the following disorders that are known to cause rapid gastric emptying: Pyloroplasty, Hemigastrectomy, Duodenal ulcer, Gastrinoma (Zollinger-Ellison syndrome), Hyperthyroidism * Current use of Thyroxine as it is known to cause rapid gastric emptying * Current or recent (within the last 2 weeks) use of anti-spasmodics or pro-kinetic medications. * Current use of Hyperalimentation * Presence of any metabolic disorder, such as: hyperglycemia, acidosis, hypokalemia, hypercalcemia, hepatic coma or myxedema. * Current use of estrogen or progesterone * Current use of the following drugs that are known to delay gastric emptying: Nifedipine, beta-adrenergic agonists, Isoproterenol, Theophylline, Sucralfate, anticholinergics, Levodopa, diazepam, tricyclic antidepressants, phenothiazine, Progesterone, oral contraceptives, alcohol, nicotine, opiates. * Allergy to eggs or wheat. * Pregnancy.

Design outcomes

Primary

Measure	Time frame
Cholecystokinin serum level	fasting- state, then at time points 30, 60 and 120 minutes post-meal
Oxytocin serum bioassay	fasting-state, and then at time points of 30, 60 and 120 minutes post-meal
Gastric Emptying time	calculated at time points 0.5, 1,2,3 and 4 hours post-meal
Perception of fullness using visual analog scales	fasting-state, and then at time points of every half hour post-meal through completion of the scan

Secondary

Measure	Time frame
Mini International Neuro-psychiatric Interview (MINI)	once within 30 days of the scan

Countries

United States

Outcome results