Back to results

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

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

NCT ID

NCT00846144

First Posted

February 17, 2009

Last Updated

February 17, 2009

Sponsor

Hadassah Medical Organization

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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs