NCT01884714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

June 18, 2013

Last Update Submit

July 6, 2016

Conditions

ObesityType-2 DiabetesMetabolic SyndromeDyslipidemia

Keywords

diabetesobesitymetabolismclinical study

Outcome Measures

Primary Outcomes (1)

  • Measure circulating inflammatory markers and fatty acids associated with obesity and diabetes.

    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.

    baseline

Secondary Outcomes (4)

  • Analyze adipose tissue gene expression in obese and diabetic subjects

    baseline

  • Measure standard clinical and anthropometric markers associated with obesity and diabetes.

    baseline

  • Examine global serum metabolite profiles associated with obesity and diabetes.

    baseline

  • Measure standard clinical and anthropometric parameters in obese and diabetic participants following a standardized meal.

    2 hours after consuming a standardized meal

Study Arms (1)

High fat/high calorie meal

EXPERIMENTAL

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

Other: High fat/high calorie meal

Interventions

High fat/high calorie mealOTHER

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

High fat/high calorie meal

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph, Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 24520395RESULT

  • 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.

    PMID: 24933025RESULT

  • 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.

    PMID: 26274804RESULT

MeSH Terms

Conditions

ObesityMetabolic SyndromeDyslipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesLipid Metabolism DisordersEndocrine System Diseases

Study Officials

  • David M Mutch, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 24, 2013

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)