Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228904
Status:
WITHDRAWN
Last Update Posted:
2016-08-10
First Post:
2005-09-27
Brief Title:
Effects of Pulsatile Intravenous Insulin Delivery on Diabetic Neuropathy in pATIENTS Pts With Type 1 and Type 2 Diabetes
Sponsor:
Florida Atlantic University
Organization:
Florida Atlantic University
Study Overview
Official Title:
Effects of Pulsatile IV Insulin Delivery on Peripheral Diabetic Neuropathy
Status:
WITHDRAWN
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic neuropathy is a progressive complication causing serious problems in 25-40 of diabetic patients Anecdotal reports have indicated improvement with pulsatile IV insulin therapy in affected patients otherwise resistant to all conventional therapies Significant complications produce painful peripheral dysesthesias loss of sensation and gastroparesis This study is designed to test the effectiveness of pulsatile IV insulin therapy on diabetic neuropathy
Detailed Description:
Diabetic neuropathy DN is a progressive complication causing serious problems in 25-40 of diabetic patients Significant complications produce painful peripheral dysesthesias loss of sensation and gastroparesis DN may affect the peripheral motor and sensory nerves in addition to the autonomic nervous system 1-3 Treatment strategies for patients with DN have generally concentrated on pain relief without addressing the underlying pathophysiology of the disease 4 Anecdotal reports from patients treated with pulsatile IV insulin therapy for other complications suggest that this treatment may show efficacy in patients with DN This study is designed to compare patients with DN who receive pulsatile IV insulin therapy with a control group
Pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs especially muscle retina liver kidney and nerve endings The process fundamentally requires the administration of high dose insulin pulses similar to those secreted by non diabetic humans by their pancreas into the surrounding portal circulation Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia The process is monitored by frequent measuring of glucose levels and respiratory quotients RQ RQ is measured by a metabolic cart which determines the ratio VCO2VO2 This ratio is specific for the fuel used at any one time by the body The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions Pulsatile IV insulin therapy is done over 1-hour periods with a 1-hour rest period between each treatment Three treatments are given during a patient visit to the center
Frequent monitoring of RQ is necessary as these levels change rapidly depending on the fuel being utilized by the body IV insulin given in pulses shifts metabolism from primarily fatty acid metabolism to primarily glucose metabolism This shift is reflected by the increase in respiratory quotient However during rest periods the RQ may fall back to lower levels Therefore RQs are done at the beginning and at the end of each insulin infusion session in order to appropriately monitor and adjust insulin and carbohydrate loads to reach optimal activation in each session
The respiratory quotient RQ is a measurement of CO2 exhaled and O2 inhaled and is proportionate to the fuel sources being used by the body primarily the liver over short periods of time The higher the RQ the more glucose and less alternative fuel sources are being utilized Following the RQ change helps determine the effectiveness of physiological insulin administration in increasing anabolic functions in diabetic individuals By improving the bodys glucose metabolism and thereby causing beneficial effects of anabolic factors the possibility of serious complications can be decreased In addition the use of oral carbohydrates at the same time along with the physiologic insulin administration stimulates the appropriate gut hormones which augment this effect a response which cannot be duplicated with intravenous glucose The purpose of our studies is to determine whether the physiologic administration of insulin along with the augmenting effect of oral carbohydrates will normalize metabolism in diabetic patients and correlate with an improvement in their manifestations of diabetic neuropathy
The RQ is determined by the use of a metabolic cart Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ The physiologic range is 07 to 13 Individuals using fat as a primary fuel have a ratio of 07 protein or mixed fuels is 08-09 and carbohydrate is 09-10 Those taking excessive calories will have RQs higher than 105 The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session
1 Tesfaye S Chaturvedi N Eaton SEM Ward JD Manes C Ionescu-Tirgoviste C witte DR Fuller JH Vascular Risk factors and Diabetic Neuropathy N Engl J Med 352341-50 2005
2 Neuropathy Trust Diabetic Neuropathy Prevalence wwwneurocentrecom
3 Potter PJ Maryniak O Yamorski R Jones IC Incidence of Peripheral Neuropathy in the Contralateral Limb of Persons with Unilateral Amputation due to Diabetes Journal of Rehabilitation Research and Development 35335-39 1998
4 Goldstein DJ Lu Y Detke MJ Lee TC Iyengan Duloxetine versus Placebo in Patients with Painful Diabetic Neuropathy Pain 116109-18 2005
Pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs especially muscle retina liver kidney and nerve endings The process fundamentally requires the administration of high dose insulin pulses similar to those secreted by non diabetic humans by their pancreas into the surrounding portal circulation Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia The process is monitored by frequent measuring of glucose levels and respiratory quotients RQ RQ is measured by a metabolic cart which determines the ratio VCO2VO2 This ratio is specific for the fuel used at any one time by the body The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions Pulsatile IV insulin therapy is done over 1-hour periods with a 1-hour rest period between each treatment Three treatments are given during a patient visit to the center
Frequent monitoring of RQ is necessary as these levels change rapidly depending on the fuel being utilized by the body IV insulin given in pulses shifts metabolism from primarily fatty acid metabolism to primarily glucose metabolism This shift is reflected by the increase in respiratory quotient However during rest periods the RQ may fall back to lower levels Therefore RQs are done at the beginning and at the end of each insulin infusion session in order to appropriately monitor and adjust insulin and carbohydrate loads to reach optimal activation in each session
The respiratory quotient RQ is a measurement of CO2 exhaled and O2 inhaled and is proportionate to the fuel sources being used by the body primarily the liver over short periods of time The higher the RQ the more glucose and less alternative fuel sources are being utilized Following the RQ change helps determine the effectiveness of physiological insulin administration in increasing anabolic functions in diabetic individuals By improving the bodys glucose metabolism and thereby causing beneficial effects of anabolic factors the possibility of serious complications can be decreased In addition the use of oral carbohydrates at the same time along with the physiologic insulin administration stimulates the appropriate gut hormones which augment this effect a response which cannot be duplicated with intravenous glucose The purpose of our studies is to determine whether the physiologic administration of insulin along with the augmenting effect of oral carbohydrates will normalize metabolism in diabetic patients and correlate with an improvement in their manifestations of diabetic neuropathy
The RQ is determined by the use of a metabolic cart Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ The physiologic range is 07 to 13 Individuals using fat as a primary fuel have a ratio of 07 protein or mixed fuels is 08-09 and carbohydrate is 09-10 Those taking excessive calories will have RQs higher than 105 The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session
1 Tesfaye S Chaturvedi N Eaton SEM Ward JD Manes C Ionescu-Tirgoviste C witte DR Fuller JH Vascular Risk factors and Diabetic Neuropathy N Engl J Med 352341-50 2005
2 Neuropathy Trust Diabetic Neuropathy Prevalence wwwneurocentrecom
3 Potter PJ Maryniak O Yamorski R Jones IC Incidence of Peripheral Neuropathy in the Contralateral Limb of Persons with Unilateral Amputation due to Diabetes Journal of Rehabilitation Research and Development 35335-39 1998
4 Goldstein DJ Lu Y Detke MJ Lee TC Iyengan Duloxetine versus Placebo in Patients with Painful Diabetic Neuropathy Pain 116109-18 2005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MH42900 and MH01386 | None | None | None |