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NCT03945435 Clinical Trial

Mechanisms of Exercise Resistance in Metabolic Disease

Impaired Glucose Tolerance Clinical Trial

Official title:
Mechanisms of Exercise Resistance in Metabolic Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03945435
Other study ID # 2017-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date April 11, 2019

Study information
Verified date August 2019
Source Joslin Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project will determine exercise capacity and molecular markers of the response to acute exercise in human subjects with impaired or normal glucose tolerance.

Description:

Low exercise capacity is an early clinical marker of metabolic impairment that predicts type 2 diabetes (T2D) risk, as well as future co-morbidities and complications. Aerobic exercise training is the only effective treatment to increase exercise capacity and reduce metabolic risk. However, despite maintaining similar levels of physical activity, exercise capacity remains lower in people with impaired glucose tolerance and T2D, compared to those with normal glucose tolerance, suggesting "exercise resistance". The mechanisms of exercise resistance in metabolic disease are unknown. In preclinical studies, exercise-induced increases in circulating angiogenic markers and skeletal muscle capillary density predict improved exercise capacity with training. Furthermore, it was demonstrated that impaired glucose tolerance precedes exercise resistance and impaired exercise-induce angiogenesis in muscle. Based on these data, it was hypothesized that exercise resistance in human T2D is caused by an impaired angiogenic response to exercise, secondary to impaired glycemic control. This study will determine whether the angiogenic response to a single bout of exercise in human subjects is blunted in patients with impaired glucose tolerance (IGT), compared to those with normal glucose tolerance (NGT). Angiogenic potential will be measured using a novel in vitro assay developed to assess endothelial tube-formation induced by circulating serum angiogenic regulators following exercise. In addition, a novel exercise-activated signaling pathway in skeletal muscle that is predictive of exercise resistance in animal models was identified. A second aim of the proposed investigation is to determine the effect of impaired glucose tolerance on molecular signaling in response to exercise in skeletal muscle. This investigation represents a critical step in determining the mechanisms that contribute to low exercise capacity in individuals at risk for diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date April 11, 2019
Est. primary completion date April 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age 18-45, BMI 26-32 kg/m2, Sedentary Lifestyle

Exclusion Criteria:

- Type 1 or Type 2 diabetes, heart or lung disease, hypertension, contraindications to exercise testing, pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Joslin Diabetes Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary VO2peak Cardiorespiratory Fitness One week
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