Clinical trial · Interventional
Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes
Influence Of Endothelial Function On Central and Peripheral Causes Of Exercise Impairment In Type 2 Diabetes
NCT00786019CI-TRIAL-00067940InsITEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Type 2 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid (Vitamin C) | Drug | — | UNRESOLVED |
| Exercise program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ascorbic acid
- description
- All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
- interventionNames
- Behavioral: Exercise program
- Drug: Ascorbic Acid (Vitamin C)
Primary outcomes (2)
- measure
- Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2 mg/dl * Renal disease
References
Publications (1)
- DERIVEDScalzo 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