Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes

NCT00786019 | Completed Results DMC

• 2 other identifiers: 07-1152UL1TR000154
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects of impaired blood flow regulation on exercise. It will also determine whether the effects are more important in the heart or in the skeletal muscle tissue during exercise. In addition, this study will decide whether temporarily reversing these problems will improve blood flow control, improve heart and muscle tissue function and help improve exercise capacity in person with type 2 diabetes. This study will do so using two methods: (1) by giving vitamin C intravenously (IV) and (2) a three month exercise training program. Up to 100 subjects will be enrolled in this study.

Conditions

Type 2 Diabetes

Keywords

Type; 2; Diabetes; Blood; Vessel; Function; Exercise; Program; Intervention; Vitamin; C; Men; Women; Blood vessel function

Outcome Measures

Primary Outcomes (2)

• Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training

  Characterize the purported cardiac dysfunction during exercise in people with type 2 diabetes (T2D). In a normal patient when measuring circumferential strain, results are negative with downward tracing (as strain is a relative change in length). Circumferential strain is a measurement of ventricular circumference within the heart vessels, measured via echocardiography.

  7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise training

• Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training

  Evaluate potential changes in cardiac function by echocardiography following 2 interventions: Three months of exercise training and acute vitamin C administration. Ejection fraction (EF) is a measurement of the percentage of blood leaving your heart each time it contracts, typically measure by echocardiography. Numbers listed are absolute EF values.

  7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training

Study Arms (1)

Ascorbic acid

EXPERIMENTAL

All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.

Behavioral: Exercise program; Drug: Ascorbic Acid (Vitamin C)

Interventions

Exercise program BEHAVIORAL

Three month exercise program located at the Anschutz Medical Campus at I-225 and Colfax. The program runs three times per week for about an hour each session. Gym is open Monday - Saturday during specific hours (morning, noon, evening).

Also known as: Exercise Training

Ascorbic acid

Ascorbic Acid (Vitamin C) DRUG

During one exercise study visit, 0.06 grams of Vitamin C per kilogram fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.

Also known as: Ascorbic Acid, Vitamin C

Ascorbic acid

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women with uncomplicated Type 2 Diabetes
• Healthy men and women without Type 2 Diabetes
• Patients with Type 2 Diabetes may be taking metformin or sulfonylurea drugs to treat diabetes
• Persons with history of hypercholesteremia if controlled with statins and/or diet
• Patients who are moderately overweight (BMI 25-37.5)
• Must be sedentary (defined as regular exercise \< 2 times a week at a low to moderate level).
• Patients with Hemoglobin A1c (HBA1C) \<8%
• Patients between the ages of 30 to 55 years
• Premenopausal women.
• Former smokers who have quit smoking for at least one year
• Absence of comorbid conditions
• Mild neuropathy is O.K. as long as it will not hamper exercise performance.
• Resting systolic blood pressure (SBP) \< 140, Resting diastolic blood pressure (DBP) \< 90
• Total Cholesterol \< 205 Triglycerides \< 250 low density lipoprotein (LDL) \< 130
• Control subjects with a normal A1C and fasting glucose

You may not qualify if:

• People with T2DM taking oral medications, other than metformin or sulfonylurea drugs 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
• Controls who have immediate family history of T2DM
• Peri-menopausal or post-menopausal women.
• Peripheral neuropathy
• Total cholesterol \> 205
• Regional wall motion abnormalities
• LV wall thickness ≥1.1 cm
• Decreased contractility (fractional shortening \<30%)
• Ischemic heart disease (abnormal resting or exercise ECG)
• Presence of angina that would limit exercise performance
• Pulmonary problems that would limit exercise performance
• Systolic blood pressure \>140 mmHg at rest or \>250 mmHg with exercise or diastolic pressure \>90 mmHg at rest or \>105 mmHg with exercise
• Persons with autonomic insufficiency, assessed by measuring variation in RR intervals with cycled breathing and by presence of a \>20 mm fall in upright blood pressure without a change in heart rate

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Diabetes Association: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Scalzo RL, Bauer TA, Harrall K, Moreau K, Ozemek C, Herlache L, McMillin S, Huebschmann AG, Dorosz J, Reusch JEB, Regensteiner JG. Acute vitamin C improves cardiac function, not exercise capacity, in adults with type 2 diabetes. Diabetol Metab Syndr. 2018 Feb 14;10:7. doi: 10.1186/s13098-018-0306-9. eCollection 2018.

  PMID: 29456629 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Limb-girdle muscular dystrophy, type 2C; Diabetes Mellitus; Motor Activity; Multiple Endocrine Neoplasia Type 1

Interventions

Resistance Training; Exercise; Ascorbic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Judith Regensteiner, PhD
• Organization: University of Colorado

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: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 12, 2023
• Results First Posted: September 11, 2018

Record last verified: 2023-07

Locations

US (1)