The Role of FTO Gene Polymorphism and Insulin Preparation in Obesity in Children With Type 1 Diabetes Mellitus (FTO_T1DM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Bialystok.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Bialystok
ClinicalTrials.gov Identifier:
NCT01279161
First received: January 18, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The project aims at assessment of the effect of the FTO gene polymorphism and the type of treatment on the development of overweight/obesity and features of metabolic syndrome in children with type 1 diabetes.

Gene polymorphism including some genetic variants may predispose to the development of cardiovascular diseases and their complications. The A allele of the FTO gene predisposing to obesity occurs in approximately 40% of the European population and each copy of this allele can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic patients may result in excess body weight gain. Therefore we need studies involving large groups of children and assessing cardiovascular risk factors in type 1 diabetes along with their genetic associations.

Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years. Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The following variables will be assessed in the treatment group: 1) Anthropometric data and questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1 or 2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the disease onset, treatment regimen, mean daily insulin consumption per kg body weight, brands of insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory data - lipid profile and blood pressure (average of three measurements). Methodology: Gene polymorphism analysis in the extracted DNA will be made with the real-time PCR method using TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and clinical variables such as BMI (including BMI increase since the disease onset), body weight and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure will be assessed by a professional statistician with a specially dedicated software. Moreover parameters such as diet and metabolic control will be assessed. As regards insulin therapy the following variables will be analysed: insulin injection device, therapy regimen (intensive versus functional; brands and types of insulin products: human insulin versus insulin analogue), consumption of insulin. All of the above listed variables will be correlated with the genotypes found in the gene polymorphism analysis. The study has been approved by Bioethics Committee of the Medical University in Białystok.

Results: The authors of the project expect that the effect of the FTO gene polymorphism on overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will be shown. Moreover the project will enable assessment of the effect of the therapeutic regimen, including the type of insulin product, on body weight increase in the course of type 1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the above associations and identification of a group at risk of excess body weight increase in the course of insulin therapy may help physicians, parents and patients to avoid this complication. Therefore clinical benefit of this project will include identification - based on the genetic assays results - of a group of type 1 diabetic children particularly likely to develop overweight, obesity and other cardiovascular risk factors.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role of FTO Gene Polymorphism and Insulin Preparation in Overweight/Obesity in Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Bialystok:

Primary Outcome Measures:
  • Identification of the effect of the FTO gene polymorphism on the development of overweight/obesity in insulin treated children [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Identification of the effect of the following factors: sex, age, duration of disease, therapy regimen, type of insulin product and degree of metabolic control on the development of overweight/ obesity in insulin treated children [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • Identification of the effect of genetic polymorphism of the FTO gene on the incidence of metabolic syndrome features in insulin treated children. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • Identification of the effect of genetic polymorphism of the FTO gene on the incidence of overweight, obesity and metabolic syndrome features in children without diabetes. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • Comparison of frequency distribution of FTO gene polymorphism involved in the pathogenesis of obesity in children with diabetes versus children without diabetes. [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Small amount of peripheral blood for isolation of DNA for assessment of FTO polymorphism.


Estimated Enrollment: 3000
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
diabetes
The study will include 1500 children with type 1 diabetes, aged 6-18 years. These will be patients from Diabetes Outpatient Clinics and patients hospitalized in Departments of Paediatrics, Endocrinology and Diabetology in University and Municipal Hospitals from Poland (Białystok, Warszawa, Łódź, Gdańsk, Wrocław, Katowice).
control
Reference group will be made of 1500 children from the above mentioned Clinics and Departments in whom type 1 diabetes was excluded. In these children diagnostics procedures will be conducted for reasons other than body weigh related diseases (excluding simple obesity). The children will not receive any treatment that might influence their body weight.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will include 1500 children with type 1 diabetes, aged 6-18 years. These will be patients from Diabetes Outpatient Clinics and patients hospitalized in Departments of Paediatrics, Endocrinology and Diabetology in University and Municipal Hospitals from all over Poland (Białystok, Warszawa, Gdańsk, Katowice, Wrocław). Reference group will be made of 1500 children from the above mentioned Clinics and Departments in whom type 1 diabetes was excluded. In these children diagnostics procedures will be conducted for reasons other than body weigh related diseases (excluding simple obesity). The children will not receive any treatment that might influence their body weight.

Criteria

Inclusion Criteria:

  • children of Polish origin
  • diagnosed with type 1 diabetes (defined according to the ADA 2010)
  • treated with insulin therapy for at least 1 year
  • aged ≥ 6 < 18 years
  • receiving the same treatment regimen for at least one year
  • insulin requirement of > 0.5 U/kg/daily

Exclusion Criteria:

  • no consent given by parents/guardians
  • chromosome disorders
  • autoimmune diseases
  • coeliac disease (biopsy-proven)
  • thyroid hormone disorders (but not the presence of antithyroid antibodies)
  • treatment that might influence body weight
  • newly diagnosed diabetes (either type 1, 2, 3 or other types of diabetes)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279161

Contacts
Contact: Wlodzimierz Luczynski, Ass. Prof. +48 85 7450-737 w.luczynski@wp.pl
Contact: Artur Bossowski, Ass. Prof. +48 85 7450-730 abossowski@hotmail.com

Locations
Poland
Department of Pediatrics, Endocrinology and Diabetology, Medical University Recruiting
Wrocław, Dolnośląskie, Poland, 50-376
Contact: Anna Noczyńska, Prof.    071 770 31 17    anocz@endo.am.wroc.pl   
Department of Pediatrics, Medical University Recruiting
Warsaw, Mazowieckie, Poland, 01-184
Contact: Agnieszka Szypowska, MD, PhD    +48 22 452 33 02    agnieszka.szypowska@gmail.com   
Department of Pediatrics, Endocrinology, Diabetology with Cardiology Division, Medical University Recruiting
Bialystok, Podlaskie, Poland, 15-089
Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University Recruiting
Gdańsk, Pomorskie, Poland, 80-211
Contact: Małgorzata Myśliwiec, Ass. Prof.    +48 58 349 28 63    mysliwiec@amg.gda.pl   
Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University Recruiting
Łódź, Łódzkie, Poland, 91-738
Contact: Agnieszka Szadkowska, Ass. Prof.    +48 42 61 77 791    agnieszka.szadkowska@wp.pl   
Department of Pediatrics, Endocrinology and Diabetology, Medical University Recruiting
Katowice, Śląskie, Poland, 40-752
Contact: Przemysława Jarosz-Chobot, Prof.    +48 202-37-62    przemka1@o2.pl   
Sponsors and Collaborators
University of Bialystok
Investigators
Study Chair: Wlodzimierz Luczynski, Ass. Prof. Medical University of Bialystok, Poland
Principal Investigator: Adam Kretowski, Prof Medical University of Bialystok, Poland
  More Information

Publications:
Responsible Party: Rector Jacek Nikliński, Medical University of Bialystok, Poland
ClinicalTrials.gov Identifier: NCT01279161     History of Changes
Other Study ID Numbers: FTO DIAB
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by University of Bialystok:
overweight, obesity, children, insulin, pump therapy, FTO

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014