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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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.

Condition Intervention
Hyperglycemia Diabetes Dietary Supplement: copper sulfate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: copper sulfate
    copper sulfate 3mg/d for a period of 6 months

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00846144

Contact: Itamar Raz, Prof 972-2-6778021

Diabetes Unit, Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Itamar Raz, Prof Hadassah Medical Organization
  More Information

Responsible Party: Prof. Itamar Raz, Hadassah Medical Organization Identifier: NCT00846144     History of Changes
Other Study ID Numbers: 0136-08-HMO
not available
Study First Received: February 17, 2009
Last Updated: February 17, 2009

Keywords provided by Hadassah Medical Organization:
Glucose stimulated insulin secretion
Reduction in insulin secretion

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Copper Sulfate
Hypoglycemic Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances
Protective Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents processed this record on August 21, 2017