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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00846144
Enrollment
100
Registered
2009-02-18
Start date
2009-09-30
Completion date
2010-12-31
Last updated
2009-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperglycemia

Keywords

Glucose stimulated insulin secretion, copper, cytokines, diabetes, Reduction in insulin secretion

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.

Interventions

DIETARY_SUPPLEMENTcopper sulfate

copper sulfate 3mg/d for a period of 6 months

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* patients with bad physical conditions

Design outcomes

Primary

MeasureTime frame
Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS.6 months

Countries

Israel

Contacts

Primary ContactItamar Raz, Prof
ntv502@netvision.net.il972-2-6778021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026