Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Sleeve gastrectomy

• Registration Number: NCT02414893
• Lead Sponsor: Consorci Sanitari del Maresme

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2015-03-25
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-10
• Last Update Submitted: 2015-04-10
• Study First Posted: 2015-04-13
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy	Sleeve gastrectomy	-

Primary Outcome Measures

Name	Time	Method
Hunger and satiety assessment by Visual Analogic Scale	4 hours

Secondary Outcome Measures

Name	Time	Method
Gastric emptying differences between groups measured by paracetamol absorption test	4 hours
Gallbladder volume differences between groups measured by ultrasonography	4 hours
Ghrelin level differences between groups	4 hours
Glucose homeostasis differences between groups	4 hours
GLP-1 level differences between groups	4 hours
CCK level differences between groups	4 hours

Trial Locations

Locations (1)

Consorci Sanitari del Maresme; 🇪🇸 Mataró, Barcelona, Spain