Relationship Between Systemic Fatty Acid Availability and... | NCT01452048

Studies
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity

NCT01452048

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Mar 21, 2022Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK077966	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

May 26, 2016Actual

Completion Date

May 26, 2016Actual

First Submitted Date

Oct 11, 2011

First Submission Date that Met QC Criteria

Oct 11, 2011

First Posted Date

Oct 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2022

Last Update Posted Date

Mar 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators specific aim is to compare the relationship between systemic fatty acid availability and insulin sensitivity in a relatively homogenous population of obese adults. The investigators anticipate 1) greater systemic fatty acid availability will be associated with lower insulin sensitivity and 2) greater systemic fatty acid availability will be associated with greater accumulation of fatty acid intermediates and pro-inflammatory markers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

38Actual

Label	Type	Description	Intervention Names
Obese Sedentary Adults, but otherwise healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin Sensitivity	A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity	2-3 hours

Secondary Outcomes

Measure	Description	Time Frame
Resting Metabolic Rate		20-30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index [BMI]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight Management Clinic (IWMC) Community Sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey F Horowitz, Ph.D.	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michigan Clincal Research Unit		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided