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Morbid ObesityNCT04170010

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

An observational study of Morbid Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morbid Obesity
How many people
45 participants
Where
1 siteGreece
Study dates
9 Dec 2019to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • For the conservatively managed cohort:
  • Morbid obesity based on BMI > 40kg/m2, managed exclusively with conservative measures (hypocaloric diet and/or increased physical activity and/or behavioral therapy)
  • Age between 18 and 65 years
  • For the bariatric cohort: Participation in NCT03851874 trial

Who cannot join

  • Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
  • Alcohol or other substance abuse
  • Use of licenced or off-label weight loss medications during the past 6 months
  • Concurrent psychiatric illness
  • Known history of diabetes mellitus (remitted cases excluded)

Trial locations and contacts

1 site in 1 country.

Alexandros Kokkinos, MD, PhD contact

+302132061248

akokkinos@med.uoa.gr

Greece1 site, 1 recruiting

  • Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

    Athens, 11527

    Alexander Kokkinos, MD, PhD, +302132061248, akokkinos@med.uoa.gr

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Conditions
Morbid Obesity
Keywords
Weight loss, Gut peptides, Meal-induced thermogenesis, Glycemia
Medical subject headings
Obesity, Morbid, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04170010
Study groupRoleWhat they receive
Conservatively managed groupIndividuals with conservatively managed obesity
Surgically managed groupIndividuals with a past history of bariatric surgery (Roux-en-Y gastric bypass/Sleeve gastrectomy) for the management of obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8-10 years following primary weight-loss intervention

  2. Change in weight, fat mass and lean body mass

    Change in weight (percentage of weight following each intervention)

    Measured: 8-10 years following primary weight-loss intervention

Secondary outcomes (9)

  1. Change in postprandial glycemia

    Change in postprandial glycemia

    Measured: 8-10 years following primary weight-loss intervention

  2. Change in postprandial insulinemia

    Change in the cumulative postprandial response for insulin

    Measured: 8-10 years following primary weight-loss intervention

  3. Change in postprandial triglyceridemia

    Change in the cumulative postprandial response for triglycerides

    Measured: 8-10 years following primary weight-loss intervention

  4. Change in Insulin resistance

    Change in Insulin resistance indices (HOMA-R, MMTT-derived Matsuda index)

    Measured: 8-10 years following primary weight-loss intervention

  5. 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

    Measured: 8-10 years following primary weight-loss intervention

  6. Change in resting metabolic rate following meal ingestion

    Change in the cumulative postprandial thermogenesis

    Measured: 8-10 years following primary weight-loss intervention

  7. Change in fasting serum adipokines

    Change of fasting leptin, adiponektin concentrations

    Measured: 8-10 years following primary weight-loss intervention

  8. Change in fasting plasma Activins and follistatins

    Change in fasting plasma Activin A, B, AB, follistatin and follistatin-like 3

    Measured: 8-10 years following primary weight-loss intervention

  9. 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

    Measured: 8-10 years following primary weight-loss intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start9 Dec 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04170010
Sponsor's protocol ID
Weight loss gut peptide study
Status last verified
Aug 2021
First submitted
18 Nov 2019
Last updated
18 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31672446

  • 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.

    PubMed 30112599

  • 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.

    PubMed 23996294

  • 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.

    PubMed 2282929

  • 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.

    PubMed 38181882

  • 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.

    PubMed 37418844

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexandros Kokkinos, MD, PhD (+302132061248, akokkinos@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04170010, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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