A study to examine post-prandial gut-hormone secretion, meal-induced thermogenesis, fasting plasma metabolomic/lipidomic and cardiovascular indices among surgically managed obese individuals in the long term compared to conservatively managed obese patients.
This is a protocol for the study of post-prandial gut peptide response and meal-induced thermogenesis in a group of 15 conservatively managed (through diet and exercise) morbidly obese individuals. During two separate visits in the study site, anthropometric and bioelectric impendence data will be collected, resting metabolic rate will be measured, and the patients will undergo a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). On a separate occasion, they will consume a standardized test mixed meal and complete visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples will be collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones. Additionally, immediately before and at 60', 120', 180' after the start of the consumption of the test meal, the resting metabolic rate of each participant will be assessed through indirect calorimetry, to quantify meal-induced thermogenesis. The observed induction of satiety and suppression of hunger, post prandial gut-peptide mobilization and change in metabolic rate will be compared to those of participants of trial no NCT03851874 (Morbidly obese patients that have undergone either Roux en Y gastric bypass or sleeve gastrectomy and participated in trial NCT03851874). Participants in the aforementioned cohort have been already followed-up during the first postoperative year and will attend the study site for another follow-up visit approximately 10 years postoperatively, whereby the same diagnostic evaluation described above will take place. Data analysis will take place within the bariatric cohort (longitudinal analysis of the effects of surgery and surgery types on anthropometric parameters, fasting and postprandial glycemia and lipemia, fasting NMR-Metabolomic/Lipidomic profiles, Indices of insulin resistance, echocardiography, energy expenditure) as well as between the two groups in a cross-sectional manner.
Study Type
OBSERVATIONAL
Enrollment
45
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, Greece
RECRUITINGChange in postprandial Gut peptide (ghrelin, Gastric Inhibitory Peptide, Secretin, Peptide Tyrosine-Tyrosine - , Glucagon-like peptide - 1, Oxyntomodulin, Glicentin) responses
Change in the cumulative postprandial response for the aforementioned gut hormones
Time frame: 8-10 years following primary weight-loss intervention
Change in weight, fat mass and lean body mass
Change in weight (percentage of weight following each intervention)
Time frame: 8-10 years following primary weight-loss intervention
Change in postprandial glycemia
Change in postprandial glycemia
Time frame: 8-10 years following primary weight-loss intervention
Change in postprandial insulinemia
Change in the cumulative postprandial response for insulin
Time frame: 8-10 years following primary weight-loss intervention
Change in postprandial triglyceridemia
Change in the cumulative postprandial response for triglycerides
Time frame: 8-10 years following primary weight-loss intervention
Change in Insulin resistance
Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index)
Time frame: 8-10 years following primary weight-loss intervention
Change in serum metabolomic and lipidomic parameters
Change in levels of lipoprotein clusters, branched-chain amino-acids, LDL/HDL-Subtypes, Trimethylamine N-oxide assessed by NMR spectroscopy
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Time frame: 8-10 years following primary weight-loss intervention
Change in resting metabolic rate following meal ingestion
Change in the cumulative postprandial thermogenesis
Time frame: 8-10 years following primary weight-loss intervention
Change in fasting serum adipokines
Change of fasting leptin, adiponektin concentrations
Time frame: 8-10 years following primary weight-loss intervention
Change in fasting plasma Activins and follistatins
Change in fasting plasma Activin A, B, AB, follistatin and follistatin-like 3
Time frame: 8-10 years following primary weight-loss intervention
Change in postprandial Visual Analog Scale scores for hunger and satiety
Change in postprandial areas under the curve of subjective hunger and satiety expressed in Visual Analog Scales
Time frame: 8-10 years following primary weight-loss intervention