Exploring the Molecular Basis to Healthy Obesity: The Diabetes Risk Assessment Study (DRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884714
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : July 11, 2016
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
David M Mutch, University of Guelph

Brief Summary:
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.

Condition or disease Intervention/treatment
Obesity Type-2 Diabetes Metabolic Syndrome Dyslipidemia Other: High fat/high calorie meal

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: New and Innovative Bioanalytical Tools to Assess Lifestyle Recommendations for Managing Type-2 Diabetes
Study Start Date : July 2011
Primary Completion Date : December 2013
Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: High fat/high calorie meal
All subjects are provided a high calorie (~1300kcal) and high fat (~60g fat) breakfast meal.
Other: High fat/high calorie meal
All subjects are provided a high calorie (~1300kcal) and high fat (~60g fat) breakfast meal.

Primary Outcome Measures :
  1. Measure circulating inflammatory markers and fatty acids associated with obesity and diabetes. [ Time Frame: baseline ]

    Common inflammatory markers (e.g. IL-6, TNFalpha, adiponection) will be measured using either standard ELISA and multiplex bead technology.

    Serum fatty acids will be measured using gas chromatography.

Secondary Outcome Measures :
  1. Analyze adipose tissue gene expression in obese and diabetic subjects [ Time Frame: baseline ]
    Gene expression analyzed using microarrays

  2. Measure standard clinical and anthropometric markers associated with obesity and diabetes. [ Time Frame: baseline ]
    Standard clinical parameters (e.g. triglycerides, cholesterol, glucose, insulin, etc) and anthropometric measurements (e.g. body mass index, waist circumference, etc) will be determined.

  3. Examine global serum metabolite profiles associated with obesity and diabetes. [ Time Frame: baseline ]
    Serum metabolites will be measured using gas chromatography coupled with mass spectrometry.

  4. Measure standard clinical and anthropometric parameters in obese and diabetic participants following a standardized meal. [ Time Frame: 2 hours after consuming a standardized meal ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

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 identifier (NCT number): NCT01884714

Canada, Ontario
University of Guelph, Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Public Health Agency of Canada (PHAC)
Principal Investigator: David M Mutch, PhD University of Guelph

Publications of Results:
Responsible Party: David M Mutch, Associate Professor, University of Guelph Identifier: NCT01884714     History of Changes
Other Study ID Numbers: 10AP033
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David M Mutch, University of Guelph:
clinical study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Lipid Metabolism Disorders