Morbid Obesity
Conditions
Keywords
Weight loss, Gut peptides, Meal-induced thermogenesis, Glycemia
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Beth Israel Deaconess Medical Center
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* For the conservatively managed cohort: 1. Morbid obesity based on BMI \> 40kg/m2, managed exclusively with conservative measures (hypocaloric diet and/or increased physical activity and/or behavioral therapy) 2. Age between 18 and 65 years * For the bariatric cohort: Participation in NCT03851874 trial
Exclusion criteria
1. Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy) 2. Alcohol or other substance abuse 3. Use of licenced or off-label weight loss medications during the past 6 months 4. Concurrent psychiatric illness 5. Known history of diabetes mellitus (remitted cases excluded)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postprandial Gut peptide (ghrelin, Gastric Inhibitory Peptide, Secretin, Peptide Tyrosine-Tyrosine - , Glucagon-like peptide - 1, Oxyntomodulin, Glicentin) responses | 8-10 years following primary weight-loss intervention | Change in the cumulative postprandial response for the aforementioned gut hormones |
| Change in weight, fat mass and lean body mass | 8-10 years following primary weight-loss intervention | Change in weight (percentage of weight following each intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin resistance | 8-10 years following primary weight-loss intervention | Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index) |
| Change in resting metabolic rate following meal ingestion | 8-10 years following primary weight-loss intervention | Change in the cumulative postprandial thermogenesis |
| Change in fasting serum adipokines | 8-10 years following primary weight-loss intervention | Change of fasting leptin, adiponektin concentrations |
| Change in fasting plasma Activins and follistatins | 8-10 years following primary weight-loss intervention | Change in fasting plasma Activin A, B, AB, follistatin and follistatin-like 3 |
| Change in postprandial Visual Analog Scale scores for hunger and satiety | 8-10 years following primary weight-loss intervention | Change in postprandial areas under the curve of subjective hunger and satiety expressed in Visual Analog Scales |
| Change in postprandial glycemia | 8-10 years following primary weight-loss intervention | Change in postprandial glycemia |
| Change in postprandial insulinemia | 8-10 years following primary weight-loss intervention | Change in the cumulative postprandial response for insulin |
| Change in postprandial triglyceridemia | 8-10 years following primary weight-loss intervention | Change in the cumulative postprandial response for triglycerides |
| Change in serum metabolomic and lipidomic parameters | 8-10 years following primary weight-loss intervention | Change in levels of lipoprotein clusters, branched-chain amino-acids, LDL/HDL-Subtypes, Trimethylamine N-oxide assessed by NMR spectroscopy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in echocardiographic cardiac phenotype | 8-10 years following primary weight-loss intervention | Change in echocardiographic cardiac structural indices and measures of systolic and diastolic function |
| Change in baroreflex sensitivity | 8-10 years following primary weight-loss intervention | Changes in baroreflex sensitivity |
| Change in heart rate variability | 8-10 years following primary weight-loss intervention | Changes in heart rate variability |
| Change in aortic distensibility | 8-10 years following primary weight-loss intervention | 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) |
Countries
Greece
Contacts
Primary ContactAlexandros Kokkinos, MD, PhD
Outcome results
None listed