Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Alan Shuldiner, University of Maryland
ClinicalTrials.gov Identifier:
NCT00981448
First received: September 18, 2009
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Diabetes
Dietary Supplement: Zinc acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change in acute insulin response from IVGTT. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in insulin sensitivity [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • change in disposition index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • self-report of history of symptoms of anemia or gastrointestinal symptoms during study [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • change in serum zinc [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • change in urinary zinc [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc supplement Dietary Supplement: Zinc acetate
50mg of elemental zinc to be administered 2 times daily orally for 14 days.
Other Name: Orazinc

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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 ClinicalTrials.gov identifier: NCT00981448

Locations
United States, Pennsylvania
Amish Research Clinic
Lancaster, Pennsylvania, United States, 17601
Sponsors and Collaborators
University of Maryland
Johns Hopkins University
Investigators
Principal Investigator: Alan R Shuldiner, MD University of Maryland, Baltimore County
  More Information

No publications 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
ClinicalTrials.gov Identifier: NCT00981448     History of Changes
Other Study ID Numbers: HP-00040355, 1KL2RR025006-01
Study First Received: September 18, 2009
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
zinc
diabetes
genetics

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014