The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients
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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: Open Label Primary Purpose: Prevention |
Official Title: | This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study. |
- Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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) |
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Dietary Supplement: copper sulfate
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
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
Contact: Itamar Raz, Prof | 972-2-6778021 | ntv502@netvision.net.il |
Israel | |
Diabetes Unit, Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
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 |
Study First Received: | February 17, 2009 |
Last Updated: | February 17, 2009 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
Glucose stimulated insulin secretion copper cytokines diabetes Reduction in insulin secretion |
Additional relevant MeSH terms:
Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Copper Copper Sulfate Trace Elements Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Emetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 26, 2012