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ClinicalTrials.gov Identifier: NCT03792685
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Medical University of Bialystok

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Diabetes Mellitus, Type 2 Metabolic Syndrome Genetic Predisposition Diet Modification Other: Normo-carbohydrate meal intake Other: High-carbohydrate meal intake Other: High-fat meal intake Other: High-protein meal intake Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : September 24, 2009
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal weight
Normal weight men. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
Other: Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.

Other: High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.

Other: High-fat meal intake
Subjects are going to receive the high-fat meal.

Other: High-protein meal intake
Subjects are going to receive the high-protein meal.

Experimental: Overweight/obesity
Men with overweight or obesity. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
Other: Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.

Other: High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.

Other: High-fat meal intake
Subjects are going to receive the high-fat meal.

Other: High-protein meal intake
Subjects are going to receive the high-protein meal.

Experimental: 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.
Other: Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.

Other: High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.

Other: High-fat meal intake
Subjects are going to receive the high-fat meal.

Other: High-protein meal intake
Subjects are going to receive the high-protein meal.




Primary Outcome Measures :
  1. The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  2. The postprandial change and differences in serum insulin concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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)

  3. The change and differences in postprandial Triglycerides (TGs) concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  4. The change and differences in postprandial Free Fatty Acids (FFAs) concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  5. The change and differences in postprandial energy expenditure levels associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  6. The change and differences in postprandial substrates (carbohydrate, fat and protein) utilization levels associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.


Secondary Outcome Measures :
  1. The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  2. The change and differences in postprandial leptin concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  3. The change and differences in postprandial adiponectin concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  4. The change and differences in postprandial peptide YY (PYY) concentrations associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.

  5. The change and differences in postprandial plasma metabolites profiles associated with investigated single nucleotide polymorphisms. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792685


Contacts
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Contact: Edyta Adamska-Patruno, PhD +48693726228 edyta.adamska@wp.pl

Locations
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Poland
Clinical Research Centre, Medical University of Bialystok Recruiting
Bialystok, Polska, Poland, 15-276
Contact: Edyta Adamska-Patruno, PhD    +48693726228    edyta.adamska@wp.pl   
Principal Investigator: Maria Gorska, Professor         
Principal Investigator: Adam Kretowski, Professor         
Sub-Investigator: Edyta Adamska-Patruno, PhD         
Sponsors and Collaborators
Medical University of Bialystok
Ministry of Science and Higher Education, Poland
Investigators
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Study Director: Edyta Adamska-Patruno, PhD Clinical Research Centre, Medical University of Bialystok
Principal Investigator: Maria Gorska, Prof. Dept of Endocrinology, Diabetology and Internal Medicine
Principal Investigator: Adam Kretowski, Prof. Dept of Endocrinology, Diabetology and Internal Medicine; Clinical Research Centre

Publications of Results:

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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03792685     History of Changes
Other Study ID Numbers: N N402 477437
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Diabetes Mellitus
Obesity
Overweight
Diabetes Mellitus, Type 2
Disease Susceptibility
Genetic Predisposition to Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Disease Attributes
Pathologic Processes