NCT00981448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

September 18, 2009

Last Update Submit

January 4, 2022

Conditions

Diabetes

Keywords

zincdiabetesgenetics

Outcome Measures

Primary Outcomes (1)

  • Change in acute insulin response from IVGTT.

    14 days

Secondary Outcomes (5)

  • change in insulin sensitivity

    14 days

  • change in disposition index

    14 days

  • self-report of history of symptoms of anemia or gastrointestinal symptoms during study

    14 days

  • change in serum zinc

    14 days

  • change in urinary zinc

    14 days

Study Arms (1)

Zinc supplement

EXPERIMENTAL
Dietary Supplement: Zinc acetate

Interventions

Zinc acetateDIETARY_SUPPLEMENT

50mg of elemental zinc to be administered 2 times daily orally for 14 days.

Also known as: Orazinc
Zinc supplement

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 21-70 years
  • Amish decent
  • genotyping of rs13266634 of SLC30A8 gene
  • previously consented to contact for future studies and future use of DNA

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amish Research Clinic

Lancaster, Pennsylvania, 17601, United States

Location

Related Publications (1)

  • Maruthur NM, Clark JM, Fu M, Linda Kao WH, Shuldiner AR. Effect of zinc supplementation on insulin secretion: interaction between zinc and SLC30A8 genotype in Old Order Amish. Diabetologia. 2015 Feb;58(2):295-303. doi: 10.1007/s00125-014-3419-1. Epub 2014 Oct 28.

    PMID: 25348609DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Zinc AcetateZinc Sulfate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Alan R Shuldiner, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

US(1)