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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

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

    • Polska
      • Bialystok, Polska, Polonia, 15-276
        • Clinical Research Centre, Medical University of Bialystok

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

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
Sperimentale: Normal weight
Normal weight men. 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: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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)
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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.
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.
Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

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

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

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 .

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