Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetes
Status unconfirmed · Phase 3
Conditions studied: Diabetes Mellitus, Metabolic Integrity
In brief
The purpose of this study is to determine if restoring normal metabolic function in patients with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic complications on the overall health and quality of life for diabetic patients.Patients are treated once per week with intensive bolus intravenous insulin delivery mimicking normal insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are performed and questionnaires completed to evaluate and monitor progress and outcomes.
Key facts
- Study ID
- NCT01023165
- Run by
- Global Infusion and Aspiration Systems, LLC
- People needed
- 2000
- Starts
- 2009-11-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2011-06-22
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with significant complications resulting from diabetes
- Ability to swallow without difficulty
- Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time Supervising physician must evaluate and diagnose one of the following medical conditions to be eligible to participate in study
- Hypoglycemia unawareness
- Significant proteinuria (>300 mg/24 hrs) in spite of ACE inhibitors and/or ARB's.
- Diabetic nephropathy
- Progressive, significant diabetic peripheral neuropathy.
- Orthostatic hypotension due to autonomic neuropathy of advanced diabetes.
- Advanced gut neuropathy with gastroparesis or diabetic diarrhea.
- Non-healing diabetic wounds
- Diabetic retinopathy
You may not qualify if…
- Lack of intravenous access
- Inability to breathe into a respiratory quotient machine
- Subjects on dialysis
- Presence of severe underlying chronic disease (e.g. coronary artery disease, hepatic disease) which in the opinion of the investigator is likely to preclude the subject from completing the full term of the study
- Inability to stabilize blood pressure at 140/90 or below using ACE inhibitors, Ca channel blockers, Alpha 1 blockers, central Alpha2 agonists or diuretics
- Pregnancy or contemplated pregnancy
- Alcohol abuse, drug addiction or the use of illegal drugs
- Active liver disease
- Active chemotherapy
- Positive HIV
- Subjects with a history of poor compliance to drug or diet or placebo therapy or keeping appointments
Where it is running
- Global Infusion and Aspiration Systems, LLC — Batesville, Mississippi, United States (enrolling)
Full record on ClinicalTrials.gov
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