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The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients

Primary Purpose

Hyperglycemia, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
copper sulfate
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Glucose stimulated insulin secretion, copper, cytokines, diabetes, Reduction in insulin secretion

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diabetic subjects with BMI < 33
  • HbA1C < 8
  • plasma copper levels of < 90 ul/dl

Exclusion Criteria:

  • patients with bad physical conditions

Sites / Locations

  • Diabetes Unit, Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2009
Last Updated
February 17, 2009
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00846144
Brief Title
The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients
Official Title
This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet, triggering a vicious sequence of events: exocrine damage, recruitment of macrophages expressing IL-1beta leading to oxidative stress and even more reduction in the activity of Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu status that may benefit from copper supplementation to normalize their GSIS. These patients will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS, pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different blood components before and every 4 weeks during treatments or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Diabetes
Keywords
Glucose stimulated insulin secretion, copper, cytokines, diabetes, Reduction in insulin secretion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
copper sulfate
Intervention Description
copper sulfate 3mg/d for a period of 6 months
Primary Outcome Measure Information:
Title
Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diabetic subjects with BMI < 33 HbA1C < 8 plasma copper levels of < 90 ul/dl Exclusion Criteria: patients with bad physical conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Itamar Raz, Prof
Phone
972-2-6778021
Email
ntv502@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamar Raz, Prof
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Unit, Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17977959
Citation
Weksler-Zangen S, Raz I, Lenzen S, Jorns A, Ehrenfeld S, Amir G, Oprescu A, Yagil Y, Yagil C, Zangen DH, Kaiser N. Impaired glucose-stimulated insulin secretion is coupled with exocrine pancreatic lesions in the Cohen diabetic rat. Diabetes. 2008 Feb;57(2):279-87. doi: 10.2337/db07-0520. Epub 2007 Oct 31.
Results Reference
background
PubMed Identifier
11679430
Citation
Weksler-Zangen S, Yagil C, Zangen DH, Ornoy A, Jacob HJ, Yagil Y. The newly inbred cohen diabetic rat: a nonobese normolipidemic genetic model of diet-induced type 2 diabetes expressing sex differences. Diabetes. 2001 Nov;50(11):2521-9. doi: 10.2337/diabetes.50.11.2521.
Results Reference
background

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The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients

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