Ignite Creation Date:
2024-05-05 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00566592
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2007-11-29
Brief Title:
The Effect of Ethanol on Overnight Glucose Regulation in Type 2
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
The Effect of Ethanol on Overnight Glucose Regulation in Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoglycemia is the principal barrier to the achievement of target glycemic goals in type 2 diabetes Alcohol consumption is very prevalent in our society and a proven cause of hypoglycemia Population studies suggest that elderly insulin requiring type 2 diabetes patients are particularly vulnerable to severe hypoglycemia and that this problem accounts for an estimated 50 million or more in healthcare costs in the USA each year We hypothesize that low dose ethanol significantly increases the vulnerability to overnight hypoglycemia and impairs the recovery of plasma glucose in elderly insulin requiring patients with type 2 diabetes Our preliminary studies suggest that low dose ethanol impairs recovery from day time insulin-induced hypoglycemia in type 2 diabetes patients but not in age matched healthy control subjects The proposed studies will examine the effects of low dose ethanol on overnight glucose regulation in elderly insulin requiring type 2 diabetes patients and will establish the mechanism of these impairments through a series of systematic evaluations Specifically these studies will document suppression of the dawn phenomenon by ethanol andor exacerbation of a deficient counterregulatory response to hypoglycemia during sleep especially growth hormone Specific mechanisms for the suppression of growth hormone to be examined include that evening ethanol 3 inhibits peak overnight ghrelin secretion andor 4 reduces pituitary sensitivity to GHRH Additionally these studies will characterize 5 the dose response characteristics of ethanol on overnight glucose homeostasis and will 6 carefully evaluate the effect of the timing of ethanol administration in relation to meal ingestion on overnight hypoglycemic vulnerability To address these aims we will assess the effect of moderate doses of orally administered ethanol or placebo on overnight growth hormone release ghrelin total IGF-1 free IGF-1 insulin-like growth factor binding protein 1 IGFBP-1 concentrations glucose production and other parameters of glucose homeostasis among elderly control subjects versus elderly insulin requiring subjects with type 2 diabetes These important studies will provide a scientific basis for the prevention of overnight hypoglycemia and the attendant cost savings by providing mechanistic insights into the causes of nocturnal hypoglycemia
Detailed Description:
None
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 |
|---|---|---|---|
| DK061990 | None | None | None |