Long Term Effects of Weight Loss on Post-prandial Gut Hormone Responses and Meal Induced Thermogenesis

Morbid Obesity Clinical Trial

Official title:

Postprandial Gut Hormone Responses and Meal-induced Thermogenesis After Non-surgical Long-term Weight Loss; Comparison With Surgically Treated Obese Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170010
• Other study ID #: Weight loss gut peptide study
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2021
• Source: National and Kapodistrian University of Athens
• Contact: Alexandros Kokkinos, MD, PhD
• Phone: +302132061248
• Email: akokkinos[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Locations

Country	Name	City	State
Greece	Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine	Athens

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in baroreflex sensitivity	Changes in baroreflex sensitivity	8-10 years following primary weight-loss intervention
Other	Change in heart rate variability	Changes in heart rate variability	8-10 years following primary weight-loss intervention
Other	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
Other	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
Primary	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
Primary	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
Secondary	Change in postprandial glycemia	Change in postprandial glycemia	8-10 years following primary weight-loss intervention
Secondary	Change in postprandial insulinemia	Change in the cumulative postprandial response for insulin	8-10 years following primary weight-loss intervention
Secondary	Change in postprandial triglyceridemia	Change in the cumulative postprandial response for triglycerides	8-10 years following primary weight-loss intervention
Secondary	Change in Insulin resistance	Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index)	8-10 years following primary weight-loss intervention
Secondary	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
Secondary	Change in resting metabolic rate following meal ingestion	Change in the cumulative postprandial thermogenesis	8-10 years following primary weight-loss intervention
Secondary	Change in fasting serum adipokines	Change of fasting leptin, adiponektin concentrations	8-10 years following primary weight-loss intervention
Secondary	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
Secondary	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