NCT02060240

Brief Summary

The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

February 6, 2014

Last Update Submit

August 2, 2019

Conditions

ObesityPrediabetic StateSedentary Lifestyle

Keywords

ObesityPrediabetic StateSedentary LifestyleInsulin ResistanceEndotheliumEicosanoidsNitric OxideRegional Blood Flow

Outcome Measures

Primary Outcomes (1)

  • Insulin mediated skeletal muslce blood flow and capillary recruitment

    Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue

    3 months

Secondary Outcomes (1)

  • Quantification of endothelial derived Vasodilators

    3 months

Other Outcomes (1)

  • Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity

    3 months

Study Arms (2)

High Activity Group

EXPERIMENTAL

Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.

Behavioral: High Activity

Standard of Care Group

NO INTERVENTION

The standard of care group will maintain their baseline level of activity for 12 weeks

Interventions

High ActivityBEHAVIORAL

The high activity group will undergo a 12 week ramped exercise protocol.

High Activity Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females ages 30-60 years of age
  • Overweight and Obese (28\< BMI \<45)
  • Confirmed pre-diabetic (5.7≤ HbA1c \< 6.5)
  • Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7

You may not qualify if:

  • Stage 3 chronic kidney disease (glomerular filtration rate \[GFR\] \< 60)
  • Obstructive Coronary artery disease
  • Congestive heart failure (ejection fraction \< 55%)
  • Peripheral vascular disease,
  • Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
  • Know hypersensitivity to Definity® ultrasound contrast agent
  • Intra-cardiac or pulmonary shunt
  • The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
  • Physical activity greater than three hours per week
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • Chadderdon SM, Belcik JT, Smith E, Pranger L, Kievit P, Grove KL, Lindner JR. Activity restriction, impaired capillary function, and the development of insulin resistance in lean primates. Am J Physiol Endocrinol Metab. 2012 Sep 1;303(5):E607-13. doi: 10.1152/ajpendo.00231.2012. Epub 2012 Jun 26.

    PMID: 22739105BACKGROUND

  • Coggins M, Lindner J, Rattigan S, Jahn L, Fasy E, Kaul S, Barrett E. Physiologic hyperinsulinemia enhances human skeletal muscle perfusion by capillary recruitment. Diabetes. 2001 Dec;50(12):2682-90. doi: 10.2337/diabetes.50.12.2682.

    PMID: 11723050BACKGROUND

  • Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.

    PMID: 16644702BACKGROUND

MeSH Terms

Conditions

ObesityPrediabetic StateSedentary BehaviorInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehaviorHyperinsulinism

Study Officials

  • Scott M Chadderdon, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Cardiovascular Medicine

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

US(1)