Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

NCT01364584 | Completed Results

• 1 other identifier: 10-0438
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research in our lab and others has established that type 2 diabetes (T2D) is associated with significantly impaired functional exercise capacity, a factor which is potentially associated with an increased risk of cardiovascular disease in those with type 2 diabetes. Of great concern, the majority of people with type 2 diabetes are sedentary and one possible reason may be that exercise, even at low levels, is perceived as being a harder effort than for nondiabetic people. Thus, treatments that may motivate patients with type 2 diabetes to be more physically active have great potential benefit. Recent observational studies suggest that glucagon-like peptide-1 agents, such as exenatide, may have a beneficial effect on endothelial and cardiac function. Because these two factors have been shown to be associated with exercise dysfunction in type 2 diabetes, the investigators hypothesize that exenatide may improve exercise capacity in those with type 2 diabetes. The aims of this study are to (1) assess whether exenatide will improve functional exercise capacity in persons with type 2 diabetes and (2) investigate the effect of exenatide on specific metabolic, endothelial, cardiac and peripheral circulatory measures of function related to changes in exercise capacity. The Investigators primary hypothesis is that exenatide will improve functional exercise capacity in people with type 2 diabetes. Having a drug that improves exercise capacity could motivate patients to exercise more and hence be a significant benefit.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption (VO2 Peak)

  Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.

  Baseline and 3 months

Secondary Outcomes (14)

• Oxygen Uptake Kinetics Steady State Tau

  Baseline and 3 months

• Change From Baseline in Arterial Stiffness

  Baseline and 3 months

• Change From Baseline in Peak Dilation of Brachial Artery Diameter

  Baseline and 3 months

• Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise

  Baseline and 3 months

• Echocardiographic Measures - Circumferential Strain

  Baseline and 3 months

Study Arms (2)

Exenatide

EXPERIMENTAL

Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Drug: Placebo

Interventions

Exenatide DRUG

Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Also known as: Byetta

Exenatide

Placebo DRUG

Subcutaneous injection 2.5 mcg-10 mcg BID

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 45 and 70 years of age
• Diagnosed with uncomplicated type 2 diabetes
• Sedentary persons (exercising not more than one time per week)
• Females who are post-menopausal
• BMI must be less than 35
• Subjects must be taking metformin for diabetes control and may also be on sulfonylurea drugs or meglitinides
• Glycosylated hemoglobin (HbA1C) \<9%
• Non-smokers or former smokers who have quit for at least 1 year
• Absence of comorbid conditions
• Resting systolic blood pressure \< 190, Resting diastolic blood pressure \< 95

You may not qualify if:

• People with type 2 diabetes (T2D) taking oral medications, other than metformin or sulfonylurea drugs or meglitinides, to control their diabetes.
• Persons treated with insulin will be excluded
• People who are currently smoking or have not quit for at least one year
• Peripheral neuropathy
• Regional wall motion abnormalities
• Left ventricular systolic dysfunction
• Ischemic heart disease (abnormal resting or exercise electrocardiogram)
• Presence of angina that would limit exercise performance
• Pulmonary problems that would limit exercise performance
• Systolic blood pressure \>190 mmHg at rest or \>250 mmHg with exercise or diastolic pressure \>95 mmHg at rest or \>115 mmHg with exercise
• Persons with autonomic dysfunction (\>20 mm fall in upright BP without a change in heart rate)
• Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2.0 mg/dl
• Renal disease
• Persons with peripheral arterial disease
• Persons with a history of pancreatitis

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Amylin Pharmaceuticals, LLC.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Judith G Regensteiner, PhD
• Organization: University of Colorado School of Medicine

judy.regensteiner@ucdenver.edu

303-724-2247

Study Officials

• Judith G Regensteiner, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: June 2, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 12, 2023
• Results First Posted: July 9, 2018

Record last verified: 2023-07

Locations

US (1)