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
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: New and Innovative Bioanalytical Tools to Assess Lifestyle Recommendations for Managing Type-2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Guelph:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  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: NCT01884714

Locations
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)
Investigators
Principal Investigator: David M Mutch, PhD University of Guelph
  More Information

No publications provided

Responsible Party: David M Mutch, Assistant Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT01884714     History of Changes
Other Study ID Numbers: 10AP033
Study First Received: June 18, 2013
Last Updated: January 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Guelph:
diabetes
obesity
metabolism
clinical study

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

ClinicalTrials.gov processed this record on September 18, 2014