NCT04791371

Brief Summary

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
10mo left

Started Jun 2022

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress83%
Jun 2022Feb 2027

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 17, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

March 8, 2021

Last Update Submit

March 19, 2026

Conditions

Type 2 DiabetesOverweight and Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in peak oxygen consumption (VO2)

    Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise

    Through study completion, approximately 4 months

  • Change in insulin sensitivity

    The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp

    Through study completion, approximately 4 months

Study Arms (2)

Type 2 Diabetes

EXPERIMENTAL

Participants aged 30-55 with type 2 diabetes

Behavioral: Cardiovascular exercise

Healthy overweight control

EXPERIMENTAL

Participants aged 30-55 with BMI 25-40 without type 2 diabetes

Behavioral: Cardiovascular exercise

Interventions

Cardiovascular exerciseBEHAVIORAL

15 weeks of cardiovascular exercise 3x/week for 50 minutes/session

Healthy overweight controlType 2 Diabetes

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary (defined as less than 1 hour per week of physical activity)
  • BMI: 25-40
  • Men and women with and without type 2 diabetes

You may not qualify if:

  • Documented cardiovascular disease
  • Uncontrolled hypertension: disease systolic blood pressure (SBP) \> 150, diastolic blood pressure (DBP)\> 110
  • Obstructive pulmonary disease or asthma
  • Peripheral neuropathy
  • Physical impairment that would limit exercise ability
  • Subjects taking beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD)
  • Current or past smoking within the last 1 years
  • Current tobacco use
  • Anemia
  • Control HbA1c \> 5.7, T2DM HbA1c \> 9
  • Pregnant, nursing or hormonal therapy (other than contraceptives)
  • Peri or post-menopausal women
  • Type 1 diabetes
  • Hepatic or renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (1)

  • Park S, Englund EK, Fujiwara T, Enge D, Schafer M, Gerstner Saucedo J, Clark EW, Abushamat LA, Scalzo RL, Fonseca B, Hunter KS, Sammel MD, Regensteiner JG, Reusch JEB, Barker AJ. Comprehensive CMR evaluation including 4D flow-derived E/A vorticity ratio in overweight adults with and without type 2 diabetes mellitus. Cardiovasc Diabetol. 2025 Dec 8;25(1):7. doi: 10.1186/s12933-025-02999-9.

    PMID: 41361416DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Juckett, MS

CONTACT

303-724-1338benjamin.juckett@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

June 17, 2022

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(2)