Copper Deficiency
Conditions
Keywords
Bariatric surgery, copper deficiency, biomarkers
Brief summary
Copper is an essential nutrient for humans and is cofactor in enzymes that participate in critical body functions. Insufficient copper can lead to hematological and neurological abnormalities that may be irreversible if left untreated. Copper deficiency is believed to be rare in the U.S. population because typical dietary intake is usually sufficient to meet requirements. More recent evidence suggests that specific populations may be susceptible to copper deficiency in cases where copper absorption in the gut is impaired following gastric surgery or in individuals with high intakes of zinc. Preliminary studies by us and others have identified significant levels of moderate and severe symptomatic copper deficiency in patients who have undergone weight loss (bariatric) gastric bypass surgery. Copper deficiency in humans is difficult to recognize and treat because current diagnostic tools rely on measures of plasma concentrations of copper and ceruloplasmin, which are neither sensitive nor specific for copper deficiency, and early warning blood markers (biomarkers) have not been identified. Recent developments indicate that copper chaperone molecules and cuproenzymes such as cytochrome C oxidase and superoxide dismutase may be more sensitive to changes in copper status, but there has been very little work done in humans. The studies outlined here are aimed at assessing copper status using these biomarkers in gastric bypass surgery patients who are at risk for symptomatic copper deficiency. In addition, patients identified to be deficient will be supplemented with copper and this treatment will be evaluated using biomarker concentrations. The findings of these studies should provide insight into the effectiveness of novel biomarkers to identify those at risk and to guide appropriate treatment to prevent serious and permanent morbidity due to copper deficiency.
Interventions
DIETARY_SUPPLEMENTCopper gluconate
4 or 8 mg copper gluconate/day will be assessed for efficacy of copper repletion
Sponsors
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
CuD subjects In order to be enrolled into the CuD Arm, subjects who have had RYGB surgery will be recruited and screened for eligibility (inclusion and
Exclusion criteria
below). Subjects whose plasma copper concentrations are in the deficient range (less than 80 μg/dL for women and less than 70 µg/dL for men, and/or ceruloplasmin activity below 62 units/L-1) following 4 weeks of supplementation with the RDA for copper will be eligible. Such supplementation is the routine standard of care with all patients undergoing RYGB surgery. This process aims to exclude patients who were only marginally copper deficient and not in need of sustained copper therapy. Subjects will be notified about their copper status by a study physician. They will be contacted by the study team, and their willingness to participate in the study will be determined. Inclusion criteria: 1) Patient has a history of RYGB weight loss surgery; 2) subject has a plasma copper level which is less than 80 μg/dL for women andl less than 70 µg/dL for men, and/or ceruloplasmin activity below 62 units/L-1; 3) subject is at least 18 but not more than 65 years of age; and 4) subject has signed an informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| copper co-enzymes | 1 year | expression of CCS, SOD and COX4 in blood samples |
Secondary
| Measure | Time frame |
|---|---|
| blood copper concentrations | 2 months |
Countries
United States
Contacts
Primary ContactNana Gletsu Miller, PhD
Outcome results
None listed