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

Diabetes Clinical Trial

Official title:

This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00846144
• Other study ID #: 0136-08-HMO
• Secondary ID: not available
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2009
• Last updated: February 17, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: Itamar Raz, Prof
• Phone: 972-2-6778021
• Email: ntv502[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• diabetic subjects with BMI < 33

• HbA1C < 8

• plasma copper levels of < 90 ul/dl

Exclusion Criteria:

• patients with bad physical conditions

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Dietary Supplement:
• copper sulfate
copper sulfate 3mg/d for a period of 6 months

Locations

Country	Name	City	State
Israel	Diabetes Unit, Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Weksler-Zangen S, Raz I, Lenzen S, Jörns 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. Epub 2007 Oct 31. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.		6 months	No