Clinical trial NCT02414893: Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients
Official title: Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients: Relation Between Hunger/Satiety, Gastric Emptying, Gallbladder Motility and Peripheral Neurohormonal Signs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A: non obese healthy individuals Group B: morbidly obese individuals Group C: individuals who had had a previous sleeve gastrectomy as a bariatric procedures

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hunger and satiety assessment by Visual Analogic Scale
timeFrame: 4 hours
Secondary outcomes:
measure: Gastric emptying differences between groups measured by paracetamol absorption test
timeFrame: 4 hours
measure: Gallbladder volume differences between groups measured by ultrasonography
timeFrame: 4 hours
measure: Ghrelin level differences between groups
timeFrame: 4 hours
measure: CCK level differences between groups
timeFrame: 4 hours
measure: GLP-1 level differences between groups
timeFrame: 4 hours
measure: Glucose homeostasis differences between groups
timeFrame: 4 hours
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
Study officials:
References:
citation: Mans E, Serra-Prat M, Palomera E, Sunol X, Clave P. Sleeve gastrectomy effects on hunger, satiation, and gastrointestinal hormone and motility responses after a liquid meal test. Am J Clin Nutr. 2015 Sep;102(3):540-7. doi: 10.3945/ajcn.114.104307. Epub 2015 Jul 22.