Investigation of Exercise Training-Induced Myokines and A... | NCT03037216

Studies
Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

NCT03037216

Sponsor

Joslin Diabetes Center

Status

Completed

Last Update Posted

Aug 20, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Exercise Intervention

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

Status Module

Record Verification Date

Aug 2020

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

Dec 15, 2016Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Jan 27, 2017

First Posted Date

Jan 31, 2017Estimated

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

Aug 19, 2020

Last Update Posted Date

Aug 20, 2020Actual

Name	Class
Daiichi Sankyo	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 purpose of this study is to find out whether exercise training leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Exercise-Training Intervention	Experimental	Subjects will undergo a 10-week aerobic exercise protocol.	Other: Exercise Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise Intervention	Other	10 Week aerobic exercise training	Experimental Exercise-Training Intervention

Measure	Description	Time Frame
Changes in circulating proteins in the blood.		Baseline vs. Post 10 Week Training.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Age between 18-35. Body mass index (BMI) must be ≥18.5 and ≤27 kg/m2. HbA1c values ≤5.7%

Exclusion Criteria:

Age <18 and >50
HbA1c ≥ 5.7%; heart or lung disease
acute systemic infection accompanied by fever, body aches, or swollen lymph glands
BMI > 27 kg/m2
current dieting or weight loss efforts
current pregnancy or breastfeeding
known history of HIV/AIDS; cancer
biochemical evidence of renal or hepatic dysfunction; renal or liver disease demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
recent blood donation
clinical history of stroke
hypertension (systolic > 140 mmHg or diastolic > 90 mmHg)
type 1 or 2 diabetes; inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurie J Goodyear, PhD	Joslin Diabetes Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joslin Diabetes Center		Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided