Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

Morbid Obesity Clinical Trial

Official title:

Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients: Relation Between Hunger/Satiety, Gastric Emptying, Gallbladder Motility and Peripheral Neurohormonal Signs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414893
• Other study ID #: 15/08
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: April 10, 2015
• Start date: September 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2015
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The mechanisms that regulate appetite in the morbidly obese are multifactorial and not well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an important role in the central regulation of appetite and hunger. Postprandial ghrelin and cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an effect on satiety sensation.

On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also promotes changes in gastric emptying which are not clearly defined.

Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and satiety in morbidly obese individuals, especially those related with gallbladder and gastric emptying, as well as those related with the response of the gastrointestinal hormones ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A) non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test after a fasting night will be administered and appetite, satiety and hormonal response (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol absorption technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Group A: non obese individuals (Body Mass Index; BMI < 30 Kg/m2) Group B: Fulfilling the National Health Institute (NHI) criteria for bariatric surgery (BMI higher than 40 Kg/m2 or 35 Kg/m2 when related comorbidities) Group C: Previous morbidly obese individuals who had had a sleeve gastrectomy at least 6 months ago.

Exclusion Criteria:

Group A: previous gastric surgery or gallbladder removal. Group B: previous gastric surgery or gallbladder removal. Group C: previous gallbladder removal.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Sleeve gastrectomy
Laparoscopic vertical gastrectomy as a bariatric procedure.

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Maresme	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger and satiety assessment by Visual Analogic Scale		4 hours	No
Secondary	Gastric emptying differences between groups measured by paracetamol absorption test		4 hours	No
Secondary	Gallbladder volume differences between groups measured by ultrasonography		4 hours	No
Secondary	Ghrelin level differences between groups		4 hours	No
Secondary	CCK level differences between groups		4 hours	No
Secondary	GLP-1 level differences between groups		4 hours	No
Secondary	Glucose homeostasis differences between groups		4 hours	No