Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792685
• Other study ID #: N N402 477437
• Status: Completed
• Phase: N/A
• Start date: September 24, 2009
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet Modification
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Metabolic Syndrome
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Other:
• Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.
• High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.
• High-fat meal intake
Subjects are going to receive the high-fat meal.
• High-protein meal intake
Subjects are going to receive the high-protein meal.

Locations

Country	Name	City	State
Poland	Clinical Research Centre, Medical University of Bialystok	Bialystok	Polska

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (19)

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 utili — View Citation

Adamska E, Ostrowska L, Adamska E, Maliszewska K, Citko A, Waszczeniuk M, Przystupa W, Majewski R, Wasilewska A, Milewski R, Krytowski A, Górska M. [Differences in dietary habits and food preferences of adults depending on the age]. Rocz Panstw Zakl Hig. — View Citation

Adamska E, Ostrowska L, Goscik J, Waszczeniuk M, Kretowski A, Górska 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. 201 — View Citation

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, Górska M. The usefulness of glycated hemoglobin A1c (HbA1c) for identifying dysglycemic — View Citation

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. 2 — View Citation

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 postprandi — View Citation

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. 201 — View Citation

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. Excessiv — View Citation

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 — View Citation

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 J — View Citation

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 20 — View Citation

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). pi — View Citation

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 — View Citation

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 var — View Citation

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. 20 — View Citation

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. — View Citation

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. Epub 2013 Jun 5. — View Citation

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 Lea — View Citation

Szczerbinski L, Goscik J, Bauer W, Wawrusiewicz-Kurylonek N, Paczkowska-Abdulsalam M, Niemira M, Citko A, Adamska-Patruno E, Górska M, Kretowski A. Efficacy of family history, genetic risk score, and physical activity in assessing the prevalence of type 2 — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.	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.
Primary	The postprandial change and differences in serum insulin concentrations associated with investigated single nucleotide polymorphisms.	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.
Primary	The change and differences in postprandial Triglycerides (TGs) concentrations associated with investigated single nucleotide polymorphisms.	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.
Primary	The change and differences in postprandial Free Fatty Acids (FFAs) concentrations associated with investigated single nucleotide polymorphisms.	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.
Primary	The change and differences in postprandial energy expenditure levels associated with investigated single nucleotide polymorphisms.	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.
Primary	The change and differences in postprandial substrates (carbohydrate, fat and protein) utilization levels associated with investigated single nucleotide polymorphisms.	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.
Secondary	The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.	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.
Secondary	The change and differences in postprandial leptin concentrations associated with investigated single nucleotide polymorphisms.	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.
Secondary	The change and differences in postprandial adiponectin concentrations associated with investigated single nucleotide polymorphisms.	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.
Secondary	The change and differences in postprandial peptide YY (PYY) concentrations associated with investigated single nucleotide polymorphisms.	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.
Secondary	The change and differences in postprandial plasma metabolites profiles associated with investigated single nucleotide polymorphisms.	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.