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

August 11, 2021 updated by: Alexandros Kokkinos, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in postprandial Gut peptide (ghrelin, Gastric Inhibitory Peptide, Secretin, Peptide Tyrosine-Tyrosine - , Glucagon-like peptide - 1, Oxyntomodulin, Glicentin) responses
Time Frame: 8-10 years following primary weight-loss intervention
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
Time Frame: 8-10 years following primary weight-loss intervention
Change in weight (percentage of weight following each intervention)
8-10 years following primary weight-loss intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in postprandial glycemia
Time Frame: 8-10 years following primary weight-loss intervention
Change in postprandial glycemia
8-10 years following primary weight-loss intervention
Change in postprandial insulinemia
Time Frame: 8-10 years following primary weight-loss intervention
Change in the cumulative postprandial response for insulin
8-10 years following primary weight-loss intervention
Change in postprandial triglyceridemia
Time Frame: 8-10 years following primary weight-loss intervention
Change in the cumulative postprandial response for triglycerides
8-10 years following primary weight-loss intervention
Change in Insulin resistance
Time Frame: 8-10 years following primary weight-loss intervention
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
Time Frame: 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
8-10 years following primary weight-loss intervention
Change in resting metabolic rate following meal ingestion
Time Frame: 8-10 years following primary weight-loss intervention
Change in the cumulative postprandial thermogenesis
8-10 years following primary weight-loss intervention
Change in fasting serum adipokines
Time Frame: 8-10 years following primary weight-loss intervention
Change of fasting leptin, adiponektin concentrations
8-10 years following primary weight-loss intervention
Change in fasting plasma Activins and follistatins
Time Frame: 8-10 years following primary weight-loss intervention
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
Time Frame: 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
8-10 years following primary weight-loss intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in baroreflex sensitivity
Time Frame: 8-10 years following primary weight-loss intervention
Changes in baroreflex sensitivity
8-10 years following primary weight-loss intervention
Change in heart rate variability
Time Frame: 8-10 years following primary weight-loss intervention
Changes in heart rate variability
8-10 years following primary weight-loss intervention
Change in aortic distensibility
Time Frame: 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)
8-10 years following primary weight-loss intervention
Change in echocardiographic cardiac phenotype
Time Frame: 8-10 years following primary weight-loss intervention
Change in echocardiographic cardiac structural indices and measures of systolic and diastolic function
8-10 years following primary weight-loss intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandros Kokkinos, MD, PhD, First Department of Propaedeutic Medicine, NKUA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Weight loss gut peptide study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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