Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Non obese

No interventions assigned to this group

Morbidly obese

No interventions assigned to this group

Sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic vertical gastrectomy as a bariatric procedure.

Interventions

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Sleeve gastrectomy

Laparoscopic vertical gastrectomy as a bariatric procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes