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

Overview

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.

Full Title of Study: “This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

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

  • patients with bad physical conditions

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Prof. Itamar Raz, Hadassah Medical Organization
  • Overall Official(s)
    • Itamar Raz, Prof, Principal Investigator, Hadassah Medical Organization
  • Overall Contact(s)
    • Itamar Raz, Prof, 972-2-6778021, ntv502@netvision.net.il

References

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.

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.

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