Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus

NCT00539409 | Terminated Phase 2 DMC

• 1 other identifier: H09-66 Main
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic quality of life questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes

Conditions

Diabetes Mellitus, With Complications

Keywords

Diabetes Mellitus; Pulsatile Intravenous Insulin Therapy; Diabetic Quality of Life; Orthostatic Hypotension; Brittle or Labile diabetes

Outcome Measures

Primary Outcomes (1)

• Monitor and assess whether Pulsatile Intravenous Insulin Therapy can effect Metabolic Integrity in patients with Diabetes Mellitus. Monitor results of QOL questionnaires, Hgb A1C levels, medications to see if patients complications improve

  Diabetes Quality of Life questionnaires are completed at baseline and every quarter thereafter, Lab values are collected at baseline and every 6 months thereafter, current medications are collected weekly

Study Arms (2)

1

NO INTERVENTION

Diabetic patients will complete quality of life questionnaires at baseline and quarterly thereafter to monitor and assess progress with complications resulting from their diabetes. Comparisons will be performed on lab values performed at baseline and every six months and medication information collected at weekly Pulsatile Intravenous Insulin treatment sessions.

Pulsatile Intravenous Insulin Therapy

ACTIVE COMPARATOR

Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)

Interventions

Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) PROCEDURE

Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session

Also known as: Humulin R, Novolog

Pulsatile Intravenous Insulin Therapy

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The researchers will include up to 750 pts between male and female between -the ages of 21 and 85 diagnosed with diabetes mellitus
• Self reporting or diagnosed with significant complications resulting from diabetes
• Taking oral agents and/or insulin for diabetic control
• Under an Endocrinologist supervision for their diabetes management, Endocrinologist must assess and approve pt for participation in this study
• Ability to swallow without difficulty
• Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time

You may not qualify if:

• Lack of Intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Active liver disease
• Active chemotherapy
• Positive HIV
• Inability to breathe into a respiratory quotient machine

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus; Hypotension, Orthostatic; Diabetes Mellitus, Type 1

Interventions

Insulin; Insulin Aspart

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Betty Tuller, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)