- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03792685
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
17 febbraio 2021 aggiornato da: Medical University of Bialystok
Analysis of Genetic Aspects of Metabolic Response on Diet With Different Content of Carbohydrate and Fat. Searching for Genetic Markers for Individualized Therapy in Patients With Obesity and Type 2 Diabetes
The objectives of this trial are to assess the effects of interactions between genetic factors and diet with various macronutrient intake on the metabolic disorders, obesity and type 2 diabetes risk, prevention, development and progress.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
This is a randomized, crossover study that includes 1 screening visit and four meal challenge test visits, separated by a 1-2-weeks washout period.
The screening will include 2000 people, males and females, to evaluate the genotype frequencies in studied population, and to find carriers of the rare genetic single nucleotide polymorphisms (SNPs), who will fulfill all the other inclusion criteria.
An oral glucose tolerance test (OGTT) will be completed at screening visit.
Moreover, the fasting blood samples will be collected for genetic analysis, and measurements of blood glucose and lipid metabolism profile, high-sensitivity C-reactive protein (hs-CRP), hormones/peptides and other factors involved in energy balance regulation.
Subjects will be asked to record their daily food intake for 3 days.
Assessments of vital signs and body height and weight, waist and hip circumferences, body fat content and body fat distribution, review of concomitant medication/supplement use and inclusion and exclusion criteria, and evaluation of adverse effects will be performed throughout the study.
To meal challenge test only men will be included, since the sex hormones may influence the study endpoints.
Subjects will be encouraged to maintain their habitual diet during wash-out periods.
During the each meal challenge test subjects will consume one of the study meals in random order.
The blood will be collected at fasting state and 30, 60, 120, 180 and 240 minutes after meal intake.
The energy expenditure and substrate utilization will be measured by indirect calorimetry method at the fasting and postprandially.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
150
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Polska
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Bialystok, Polska, Polonia, 15-276
- Clinical Research Centre, Medical University of Bialystok
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Maschio
Descrizione
Inclusion Criteria:
- healthy men with normal body weight and with overweight/obesity
- men with metabolic syndrome, hypertension, type 2 diabetes newly diagnosed, or not treated with any medicines
- maintaining the usual diet and lifestyle throughout the study
Exclusion Criteria:
- infectious or acute diseases in the last 4 weeks before the study visits
- any medicines/dietary supplements consumption in the last 4 weeks before the study visits
- high level of daily physical activity
- the following any special diet or dietary patterns (vegetarian, high-fat etc.)
- the presence of any other significant disease which may affect the results (hormonal disorders, history of any surgeries on gastrointestinal tract, allergies known or suspected, heart failure, history of cancer, any kidney, pancrea and liver diseases, except non-alcoholic fatty liver)
- abusive alcohol consumption
- abusive coffee or energy drinks consumption
- drug consumption
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Normal weight
Normal weight men.
Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
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Subjects are going to receive the normo-carbohydrate meal.
Subjects are going to receive the high-carbohydrate meal.
Subjects are going to receive the high-fat meal.
Subjects are going to receive the high-protein meal.
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Sperimentale: Overweight/obesity
Men with overweight or obesity.
Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
|
Subjects are going to receive the normo-carbohydrate meal.
Subjects are going to receive the high-carbohydrate meal.
Subjects are going to receive the high-fat meal.
Subjects are going to receive the high-protein meal.
|
|
Sperimentale: Diabetes
Men with prediabetes or type 2 diabetes mellitus.
Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
|
Subjects are going to receive the normo-carbohydrate meal.
Subjects are going to receive the high-carbohydrate meal.
Subjects are going to receive the high-fat meal.
Subjects are going to receive the high-protein meal.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in blood glucose concentrations (mg/dL) will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in serum insulin concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in serum insulin concentrations (IU/mL) will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content)
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial Triglycerides (TGs) concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in blood TGs (mg/dL) concentrations will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial Free Fatty Acids (FFAs) concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in blood FFAs (umol/L) concentrations will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial energy expenditure levels associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
|
The postprandial change and differences in energy expenditure levels (kcal/min) will be evaluated by indirect calorimetry method, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
|
Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
|
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The change and differences in postprandial substrates (carbohydrate, fat and protein) utilization levels associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
|
The postprandial change and differences in substrates (carbohydrate, fat and protein) utilization (mg/min) will be evaluated by indirect calorimetry method, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
|
Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
|
The postprandial change and differences in blood ghrelin concentrations (pg/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial leptin concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in blood leptin concentrations (ng/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial adiponectin concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The postprandial change and differences in blood adiponectin concentrations (ng/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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The change and differences in postprandial peptide YY (PYY) concentrations associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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The postprandial change and differences in blood PYY (pg/mL) concentrations will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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The change and differences in postprandial plasma metabolites profiles associated with investigated single nucleotide polymorphisms.
Lasso di tempo: Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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The postprandial change and differences in plasma metabolites profiles (metabolomic fingerprinting) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
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Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Edyta Adamska-Patruno, PhD, Clinical Research Centre, Medical University of Bialystok
- Investigatore principale: Maria Gorska, Prof., Dept of Endocrinology, Diabetology and Internal Medicine
- Investigatore principale: Adam Kretowski, Prof., Dept of Endocrinology, Diabetology and Internal Medicine; Clinical Research Centre
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Adamska E, Ostrowska L, Goscik J, Waszczeniuk M, Kretowski A, Gorska M. Intake of Meals Containing High Levels of Carbohydrates or High Levels of Unsaturated Fatty Acids Induces Postprandial Dysmetabolism in Young Overweight/Obese Men. Biomed Res Int. 2015;2015:147196. doi: 10.1155/2015/147196. Epub 2015 Nov 2.
- Ciborowski M, Adamska E, Rusak M, Godzien J, Wilk J, Citko A, Bauer W, Gorska M, Kretowski A. CE-MS-based serum fingerprinting to track evolution of type 2 diabetes mellitus. Electrophoresis. 2015 Sep;36(18):2286-2293. doi: 10.1002/elps.201500021. Epub 2015 Jun 26.
- Kretowski A, Adamska E, Maliszewska K, Wawrusiewicz-Kurylonek N, Citko A, Goscik J, Bauer W, Wilk J, Golonko A, Waszczeniuk M, Lipinska D, Hryniewicka J, Niemira M, Paczkowska M, Ciborowski M, Gorska M. The rs340874 PROX1 type 2 diabetes mellitus risk variant is associated with visceral fat accumulation and alterations in postprandial glucose and lipid metabolism. Genes Nutr. 2015 Mar;10(2):4. doi: 10.1007/s12263-015-0454-6. Epub 2015 Jan 20.
- Ostrowska L, Fiedorczuk J, Adamska E. Effect of diet and other factors on serum adiponectin concentrations in patients with type 2 diabetes. Rocz Panstw Zakl Hig. 2013;64(1):61-6.
- Ostrowska L, Witczak K, Adamska E. Effect of nutrition and atherogenic index on the occurrence and intensity of insulin resistance. Pol Arch Med Wewn. 2013;123(6):289-96. doi: 10.20452/pamw.1774. Epub 2013 Jun 5.
- Adamska E, Ostrowska L, Adamska E, Maliszewska K, Citko A, Waszczeniuk M, Przystupa W, Majewski R, Wasilewska A, Milewski R, Krytowski A, Gorska M. [Differences in dietary habits and food preferences of adults depending on the age]. Rocz Panstw Zakl Hig. 2012;63(1):73-81. Polish.
- Adamska E, Waszczeniuk M, Goscik J, Golonko A, Wilk J, Pliszka J, Maliszewska K, Lipinska D, Milewski R, Wasilewska A, Citko A, Nikolajuk A, Ostrowska L, Kretowski A, Gorska M. The usefulness of glycated hemoglobin A1c (HbA1c) for identifying dysglycemic states in individuals without previously diagnosed diabetes. Adv Med Sci. 2012;57(2):296-301. doi: 10.2478/v10039-012-0030-x.
- Adamska-Patruno E, Ostrowska L, Golonko A, Pietraszewska B, Goscik J, Kretowski A, Gorska M. Evaluation of Energy Expenditure and Oxidation of Energy Substrates in Adult Males after Intake of Meals with Varying Fat and Carbohydrate Content. Nutrients. 2018 May 16;10(5):627. doi: 10.3390/nu10050627.
- Adamska E, Kretowski A, Goscik J, Citko A, Bauer W, Waszczeniuk M, Maliszewska K, Paczkowska-Abdulsalam M, Niemira M, Szczerbinski L, Ciborowski M, Gorska M. The type 2 diabetes susceptibility TCF7L2 gene variants affect postprandial glucose and fat utilization in non-diabetic subjects. Diabetes Metab. 2018 Sep;44(4):379-382. doi: 10.1016/j.diabet.2017.05.001. Epub 2017 May 31. No abstract available.
- Adamska-Patruno E, Ostrowska L, Goscik J, Pietraszewska B, Kretowski A, Gorska M. The relationship between the leptin/ghrelin ratio and meals with various macronutrient contents in men with different nutritional status: a randomized crossover study. Nutr J. 2018 Dec 28;17(1):118. doi: 10.1186/s12937-018-0427-x.
- Adamska-Patruno E, Goscik J, Czajkowski P, Maliszewska K, Ciborowski M, Golonko A, Wawrusiewicz-Kurylonek N, Citko A, Waszczeniuk M, Kretowski A, Gorska M. The MC4R genetic variants are associated with lower visceral fat accumulation and higher postprandial relative increase in carbohydrate utilization in humans. Eur J Nutr. 2019 Oct;58(7):2929-2941. doi: 10.1007/s00394-019-01955-0. Epub 2019 Apr 3.
- Godzien J, Kalaska B, Adamska-Patruno E, Siroka J, Ciborowski M, Kretowski A, Barbas C. Oxidized glycerophosphatidylcholines in diabetes through non-targeted metabolomics: Their annotation and biological meaning. J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Jul 1;1120:62-70. doi: 10.1016/j.jchromb.2019.04.053. Epub 2019 Apr 29.
- Szczerbinski L, Goscik J, Bauer W, Wawrusiewicz-Kurylonek N, Paczkowska-Abdulsalam M, Niemira M, Citko A, Adamska-Patruno E, Gorska M, Kretowski A. Efficacy of family history, genetic risk score, and physical activity in assessing the prevalence of type 2 diabetes. Pol Arch Intern Med. 2019 Aug 29;129(7-8):442-450. doi: 10.20452/pamw.14866. Epub 2019 Jun 6.
- Adamska-Patruno E, Samczuk P, Ciborowski M, Godzien J, Pietrowska K, Bauer W, Gorska M, Barbas C, Kretowski A. Metabolomics Reveal Altered Postprandial Lipid Metabolism After a High-Carbohydrate Meal in Men at High Genetic Risk of Diabetes. J Nutr. 2019 Jun 1;149(6):915-922. doi: 10.1093/jn/nxz024.
- Adamska-Patruno E, Godzien J, Ciborowski M, Samczuk P, Bauer W, Siewko K, Gorska M, Barbas C, Kretowski A. The Type 2 Diabetes Susceptibility PROX1 Gene Variants Are Associated with Postprandial Plasma Metabolites Profile in Non-Diabetic Men. Nutrients. 2019 Apr 19;11(4):882. doi: 10.3390/nu11040882.
- Maliszewska K, Adamska-Patruno E, Goscik J, Lipinska D, Citko A, Krahel A, Miniewska K, Fiedorczuk J, Moroz M, Gorska M, Kretowski A. The Role of Muscle Decline in Type 2 Diabetes Development: A 5-Year Prospective Observational Cohort Study. Nutrients. 2019 Apr 12;11(4):834. doi: 10.3390/nu11040834.
- Adamska-Patruno E, Ostrowska L, Goscik J, Fiedorczuk J, Moroz M, Kretowski A, Gorska M. The Differences in Postprandial Serum Concentrations of Peptides That Regulate Satiety/Hunger and Metabolism after Various Meal Intake, in Men with Normal vs. Excessive BMI. Nutrients. 2019 Feb 26;11(3):493. doi: 10.3390/nu11030493.
- Czajkowski P, Adamska-Patruno E, Bauer W, Fiedorczuk J, Krasowska U, Moroz M, Gorska M, Kretowski A. The Impact of FTO Genetic Variants on Obesity and Its Metabolic Consequences is Dependent on Daily Macronutrient Intake. Nutrients. 2020 Oct 23;12(11):3255. doi: 10.3390/nu12113255.
- Paczkowska-Abdulsalam M, Niemira M, Bielska A, Szalkowska A, Raczkowska BA, Junttila S, Gyenesei A, Adamska-Patruno E, Maliszewska K, Citko A, Szczerbinski L, Kretowski A. Evaluation of Transcriptomic Regulations behind Metabolic Syndrome in Obese and Lean Subjects. Int J Mol Sci. 2020 Feb 20;21(4):1455. doi: 10.3390/ijms21041455.
- Bauer W, Adamska-Patruno E, Krasowska U, Moroz M, Fiedorczuk J, Czajkowski P, Bielska D, Gorska M, Kretowski A. Dietary Macronutrient Intake May Influence the Effects of TCF7L2 rs7901695 Genetic Variants on Glucose Homeostasis and Obesity-Related Parameters: A Cross-Sectional Population-Based Study. Nutrients. 2021 Jun 4;13(6):1936. doi: 10.3390/nu13061936.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
24 settembre 2009
Completamento primario (Effettivo)
1 giugno 2020
Completamento dello studio (Effettivo)
1 gennaio 2021
Date di iscrizione allo studio
Primo inviato
26 dicembre 2018
Primo inviato che soddisfa i criteri di controllo qualità
1 gennaio 2019
Primo Inserito (Effettivo)
3 gennaio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 febbraio 2021
Ultimo verificato
1 febbraio 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema endocrino
- Attributi della malattia
- Ipernutrizione
- Disturbi della nutrizione
- Peso corporeo
- Resistenza all'insulina
- Iperinsulinismo
- Diabete mellito
- Diabete mellito, tipo 2
- Obesità
- Sindrome metabolica
- Sovrappeso
- Suscettibilità alle malattie
- Predisposizione genetica alla malattia
Altri numeri di identificazione dello studio
- N N402 477437
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .