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

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ClinicalTrials.gov Identifier: NCT00846144
Recruitment Status : Unknown
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Diabetes Dietary Supplement: copper sulfate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

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


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


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with bad physical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846144


Contacts
Contact: Itamar Raz, Prof 972-2-6778021 ntv502@netvision.net.il

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

Publications:
Responsible Party: Prof. Itamar Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00846144     History of Changes
Other Study ID Numbers: 0136-08-HMO
not available
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Copper
Copper Sulfate
Hypoglycemic Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Antidotes
Protective Agents
Emetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents