Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT00981448
• Collaborator: Johns Hopkins University (Other)
• Enrollment: 57
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Dietary Supplement: Zinc acetate	N/A

Detailed Description

As diabetes increases at an alarming rate, strategies for prevention of this disease must be developed. For a given individual, there are both biologic (e.g., genetic) and environmental (e.g., lifestyle) factors that comprise her individual risk of diabetes. Researchers can take advantage the accumulating knowledge of these individual factors to design individualized strategies for diabetes risk assessment and prevention. For example, a mutation in a particular gene, SLC30A8, which encodes a zinc transporter, has been shown to increase the risk of diabetes probably through impairment of insulin secretion. In the proposed research project, the investigators aim to conduct a pilot study to see the effect of zinc supplementation on insulin secretion in people with and without this genetic mutation to see if zinc can improve insulin secretion in those with the mutation. The results from this study will help the investigators to plan a larger, more definitive study to determine if zinc supplementation can be used to prevent or treat diabetes in those with this mutation in SLC30A8.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zinc supplement	Dietary Supplement: Zinc acetate; 50mg of elemental zinc to be administered 2 times daily orally for 14 days.; Other Names: Orazinc

Outcome Measures

Primary Outcome Measures

1. Change in acute insulin response from IVGTT. [14 days]

Secondary Outcome Measures

1. change in insulin sensitivity [14 days]

2. change in disposition index [14 days]

3. self-report of history of symptoms of anemia or gastrointestinal symptoms during study [14 days]

4. change in serum zinc [14 days]

5. change in urinary zinc [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• aged 21-70 years

• Amish decent

• genotyping of rs13266634 of SLC30A8 gene

• previously consented to contact for future studies and future use of DNA

Exclusion Criteria:

• Subject is a first-degree relative of another subject with the same SLC30A8 genotype

• diabetes mellitus (by history, treatment or random BG>200 mg;dl)

• gastrointestinal disease causing nausea, vomiting, or diarrhea including inflammatory bowel disease by history.

• rheumatoid arthritis by history

• albumin < 3.5 g/dL

• hemochromatosis by history

• hematocrit <34%

• liver disease by history

• alanine aminotransferase or aspartate aminotransferase greater than 2.5 times normal

• renal failure by history

• estimated glomerular filtration rate < 60 mL/min by MDRD equation

• use of thiazide diuretic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation

• use of systemic corticosteroid and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation

• use of highly-active antiretroviral medications

• use of antipsychotic medications

• use of quinolone antibiotics

• use of tetracycline antibiotic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation

• use of chelation therapy in the past month

• unwilling to withdraw from supplements for 1 week prior to the study and throughout study

• abnormal thyroid stimulating hormone (TSH) level

• serious disease precluding participation

• reported pregnancy or positive urine hCG test

• cancer diagnosis in past 2 years

• breastfeeding

• use of denture adhesive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amish Research Clinic	Lancaster	Pennsylvania	United States	17601

Sponsors and Collaborators

• University of Maryland, Baltimore
• Johns Hopkins University

Investigators

• Principal Investigator: Alan R Shuldiner, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alan Shuldiner, Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT00981448
• Other Study ID Numbers: HP-00040355; 1KL2RR025006-01
• First Posted: Sep 22, 2009
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Alan Shuldiner, Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition, University of Maryland, Baltimore: zinc; diabetes; genetics
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Jan 20, 2022