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

• Conditions: Morbid Obesity

• Registration Number: NCT04170010
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2019-12-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-18
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 resting metabolic rate following meal ingestion	8-10 years following primary weight-loss intervention	Change in the cumulative postprandial thermogenesis
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
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 Insulin resistance	8-10 years following primary weight-loss intervention	Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index)
Change in fasting serum adipokines	8-10 years following primary weight-loss intervention	Change of fasting leptin, adiponektin concentrations

Trial Locations

Locations (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine; 🇬🇷 Athens, Greece