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

NCT ID: NCT01884714

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Obesity; Type-2 Diabetes; Metabolic Syndrome; Dyslipidemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High fat/high calorie meal

All subjects are provided a high calorie (\~1300kcal) and high fat (\~60g fat) breakfast meal.

Group Type: EXPERIMENTAL

High fat/high calorie meal

Intervention Type: OTHER

All subjects are provided a high calorie (\~1300kcal) and high fat (\~60g fat) breakfast meal.

Interventions

High fat/high calorie meal

All subjects are provided a high calorie (\~1300kcal) and high fat (\~60g fat) breakfast meal.

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

David M Mutch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Mutch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

University of Guelph, Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Countries

Canada

References

Perreault M, Zulyniak MA, Badoud F, Stephenson S, Badawi A, Buchholz A, Mutch DM. A distinct fatty acid profile underlies the reduced inflammatory state of metabolically healthy obese individuals. PLoS One. 2014 Feb 10;9(2):e88539. doi: 10.1371/journal.pone.0088539. eCollection 2014.

Reference Type: RESULT

PMID: 24520395 (View on PubMed)

Badoud F, Lam KP, DiBattista A, Perreault M, Zulyniak MA, Cattrysse B, Stephenson S, Britz-McKibbin P, Mutch DM. Serum and adipose tissue amino acid homeostasis in the metabolically healthy obese. J Proteome Res. 2014 Jul 3;13(7):3455-66. doi: 10.1021/pr500416v. Epub 2014 Jun 23.

Reference Type: RESULT

PMID: 24933025 (View on PubMed)

Badoud F, Lam KP, Perreault M, Zulyniak MA, Britz-McKibbin P, Mutch DM. Metabolomics Reveals Metabolically Healthy and Unhealthy Obese Individuals Differ in their Response to a Caloric Challenge. PLoS One. 2015 Aug 14;10(8):e0134613. doi: 10.1371/journal.pone.0134613. eCollection 2015.

Reference Type: RESULT

PMID: 26274804 (View on PubMed)

Other Identifiers

10AP033

Identifier Type: -

Identifier Source: org_study_id