Diabetes Risk Assessment Study (DRA)

This study has been completed.
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
David M Mutch, University of Guelph
ClinicalTrials.gov Identifier:
NCT01884714
First received: June 18, 2013
Last updated: January 19, 2014
Last verified: January 2014

June 18, 2013
January 19, 2014
July 2011
December 2013   (final data collection date for primary outcome measure)
  • Measure circulating inflammatory markers associated with obesity and diabetes. [ Time Frame: baseline fasting ] [ Designated as safety issue: No ]
    Common inflammatory markers (e.g. IL-6, TNFalpha, adiponection) will be measured using either standard ELISA and multiplex bead technology.
  • Measure serum fatty acids profiles associated with obesity and diabetes. [ Time Frame: baseline fasting ] [ Designated as safety issue: No ]
    Serum fatty acids will be measured using gas chromatography.
  • Examine global serum metabolite profiles associated with obesity and diabetes. [ Time Frame: baseline fasting ] [ Designated as safety issue: No ]
    Serum metabolites will be measured using gas chromatography coupled with mass spectrometry.
  • Measure standard clinical and anthropometric markers associated with obesity and diabetes. [ Time Frame: baseline fasting ] [ Designated as safety issue: No ]
    Standard clinical parameters (e.g. triglycerides, cholesterol, glucose, insulin, etc) and anthropometric measurements (e.g. body mass index, waist circumference, etc) will be determined.
  • Analyze adipose tissue gene expression in obese and diabetic subjects [ Time Frame: baseline fasting ] [ Designated as safety issue: No ]
    Targeted gene expression will be analyzed by real-time RT-PCR.
Same as current
Complete list of historical versions of study NCT01884714 on ClinicalTrials.gov Archive Site
Measure standard clinical and anthropometric parameters in obese and diabetic participants following a standardized meal. [ Time Frame: 2 hours after meal ] [ Designated as safety issue: No ]
All subjects will be provided a standardized meal and after 2 hours standard clinical parameters (e.g. triglycerides, cholesterol, glucose, insulin, etc) will be determined.
Same as current
Not Provided
Not Provided
 
Diabetes Risk Assessment Study
New and Innovative Bioanalytical Tools to Assess Lifestyle Recommendations for Managing Type-2 Diabetes

The purpose of this study is to better understand the genetic and metabolic differences in obese individuals with and without type 2 diabetes. It is expected that this research will help improve our understanding of the variability observed between obese and diabetic individuals.

PURPOSE: Diabetes is one of the fastest growing diseases in Canada; however, lifestyle changes (e.g. changes in diet and physical activity) can prevent or postpone the development of this metabolic disease. The proposed research project hypothesizes that knowledge of the diabetic and obese metabolic phenotype (i.e. the metabotype) has value in predicting these diseases, preventing their downstream complications, and personalizing therapeutic and lifestyle interventions to improve diabetes and obesity management. The overall purpose of this research is to identify biomarkers that uniquely reflect the metabolic perturbations associated with type 2 diabetes and obesity. This information will be invaluable in the design of more personalized interventions to manage these disease states

RATIONALE: Type-2 diabetes is a disease state that affects multiple organs of the biological system, including alterations in adipocyte and muscle insulin signalling, hepatic glucose production, glucose absorption from the gastrointestinal tract, and pancreatic insulin deficiency caused by the loss of β-cell mass and function. Understanding the molecular communication taking place both within and between these tissues is paramount to unravel the metabolic regulatory networks and mechanisms underlying diabetes. Global gene expression profiling (i.e. transcriptomics) and metabolite profiling (i.e. metabolomics) offer powerful approaches to understand the biological processes associated with diabetes and obesity. The analysis of gene expression profiles provides an opportunity to identify early markers of metabolic dysregulation. In contrast, metabolites represent an endpoint of gene and protein function; thus metabolomics is ideally suited for the identification of biomarkers that reflect the biochemical processes underlying a physiological state. By integrating gene expression profiling with metabolite profiling, we will have the opportunity to improve our understanding of the metabolic perturbations related to obesity and/or type-2 diabetes.

OBJECTIVES: The specific goals of this project are to:

  1. Recruit a sample of lean, lean/diabetic, obese, and obese/diabetic research participants from the Guelph community.
  2. Assess blood glucose and insulin levels in these 4 groups both at baseline and after the consumption of a standardized high fat/high calorie meal.
  3. Define the metabotype of these 4 groups by profiling plasma metabolites with mass spectrometry. The current study will examine only blood metabolites.
  4. Define subcutaneous adipose tissue gene expression profiles of these 4 groups using microarray technology.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Obesity
  • Type-2 Diabetes
  • Metabolic Syndrome
  • Dyslipidemia
Other: High fat/high calorie meal
All subjects are provided a high calorie (~1300kcal) and high fat (~60g fat) breakfast meal.
Experimental: High fat/high calorie meal
All subjects are provided a high calorie (~1300kcal) and high fat (~60g fat) breakfast meal.
Intervention: Other: High fat/high calorie meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable body weight (± 2 kg) for at least 3 months.

Exclusion Criteria:

  • Evidence of acute or chronic inflammatory disease
  • Infectious diseases
  • Viral infection
  • Cancer
  • Alcohol consumption (i.e. more than 2 drinks/day, where 1 drink = 10 g alcohol).
Both
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01884714
10AP033
No
David M Mutch, University of Guelph
University of Guelph
Public Health Agency of Canada (PHAC)
Principal Investigator: David M Mutch, PhD University of Guelph
University of Guelph
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP