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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservatively managed group | Individuals with conservatively managed obesity | ||
| Surgically managed group | Individuals with a past history of bariatric surgery (Roux-en-Y gastric bypass/Sleeve gastrectomy) for the management of obesity |
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| Measure | Description | Time Frame |
|---|---|---|
| Change 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 | 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) | 8-10 years following primary weight-loss intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial glycemia | Change in postprandial glycemia | 8-10 years following primary weight-loss intervention |
| Change in postprandial insulinemia | Change in the cumulative postprandial response for insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baroreflex sensitivity | Changes in baroreflex sensitivity | 8-10 years following primary weight-loss intervention |
| Change in heart rate variability | Changes in heart rate variability |
Inclusion Criteria:
For the conservatively managed cohort:
For the bariatric cohort: Participation in NCT03851874 trial
Exclusion Criteria:
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Intervention group: participants of NCT03851874 trial Control group: conservatively (non-surgically, non-pharmaceutically) managed obese individuals among ambulatory patients of the obesity outpatient clinic of the 1st Department of Propaedeutic Internal Medicine ("Laiko" General Hospital)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandros Kokkinos, MD, PhD | Contact | +302132061248 | akokkinos@med.uoa.gr |
| Name | Affiliation | Role |
|---|---|---|
| Alexandros Kokkinos, MD, PhD | First Department of Propaedeutic Medicine, NKUA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine | Recruiting | Athens | 11527 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31672446 | Background | Perakakis N, Kokkinos A, Peradze N, Tentolouris N, Ghaly W, Pilitsi E, Upadhyay J, Alexandrou A, Mantzoros CS. Circulating levels of gastrointestinal hormones in response to the most common types of bariatric surgery and predictive value for weight loss over one year: Evidence from two independent trials. Metabolism. 2019 Dec;101:153997. doi: 10.1016/j.metabol.2019.153997. Epub 2019 Oct 28. | |
| 30112599 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Plasma and serum
| 8-10 years following primary weight-loss intervention |
| Change in postprandial triglyceridemia | Change in the cumulative postprandial response for triglycerides | 8-10 years following primary weight-loss intervention |
| Change in Insulin resistance | Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index) | 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 | 8-10 years following primary weight-loss intervention |
| Change in resting metabolic rate following meal ingestion | Change in the cumulative postprandial thermogenesis | 8-10 years following primary weight-loss intervention |
| Change in fasting serum adipokines | Change of fasting leptin, adiponektin concentrations | 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 | 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 | 8-10 years following primary weight-loss intervention |
| 8-10 years following primary weight-loss intervention |
| Change in aortic distensibility | Aortic distensibility will be evaluated by calculating the systolic and diastolic aortic diameter through M-mode echocardiography, 3 cm above the aortic valve, using the formula described in reference no 4 (PMID: 2282929) | 8-10 years following primary weight-loss intervention |
| Change in echocardiographic cardiac phenotype | Change in echocardiographic cardiac structural indices and measures of systolic and diastolic function | 8-10 years following primary weight-loss intervention |
| Background |
| Liaskos C, Koliaki C, Alexiadou K, Argyrakopoulou G, Tentolouris N, Diamantis T, Alexandrou A, Katsilambros N, Kokkinos A. Roux-en-Y Gastric Bypass Is More Effective than Sleeve Gastrectomy in Improving Postprandial Glycaemia and Lipaemia in Non-diabetic Morbidly Obese Patients: a Short-term Follow-up Analysis. Obes Surg. 2018 Dec;28(12):3997-4005. doi: 10.1007/s11695-018-3454-y. |
| 23996294 | Background | Yousseif A, Emmanuel J, Karra E, Millet Q, Elkalaawy M, Jenkinson AD, Hashemi M, Adamo M, Finer N, Fiennes AG, Withers DJ, Batterham RL. Differential effects of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on appetite, circulating acyl-ghrelin, peptide YY3-36 and active GLP-1 levels in non-diabetic humans. Obes Surg. 2014 Feb;24(2):241-52. doi: 10.1007/s11695-013-1066-0. |
| 2282929 | Background | Stefanadis C, Stratos C, Boudoulas H, Kourouklis C, Toutouzas P. Distensibility of the ascending aorta: comparison of invasive and non-invasive techniques in healthy men and in men with coronary artery disease. Eur Heart J. 1990 Nov;11(11):990-6. doi: 10.1093/oxfordjournals.eurheartj.a059639. |
| 38181882 | Derived | Kokkinos A, Tsilingiris D, Simati S, Stefanakis K, Angelidi AM, Tentolouris N, Anastasiou IA, Connelly MA, Alexandrou A, Mantzoros CS. Bariatric surgery, through beneficial effects on underlying mechanisms, improves cardiorenal and liver metabolic risk over an average of ten years of observation: A longitudinal and a case-control study. Metabolism. 2024 Mar;152:155773. doi: 10.1016/j.metabol.2023.155773. Epub 2024 Jan 3. |
| 37418844 | Derived | Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |