DiabetesNCT00981448
Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
A study testing Zinc acetate in people with Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Zinc acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 21-70 years
- Amish decent
- genotyping of rs13266634 of SLC30A8 gene
- previously consented to contact for future studies and future use of DNA
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Amish Research Clinic
Lancaster, Pennsylvania, 17601
About this study
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Zinc acetate
- Keywords
- zinc, diabetes, genetics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc acetateDietary supplement
Also called Orazinc
50mg of elemental zinc to be administered 2 times daily orally for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Zinc supplement | Experimental | Not described Receives: Dietary Supplement: Zinc acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute insulin response from IVGTT.
Measured: 14 days
Secondary outcomes (5)
change in insulin sensitivity
Measured: 14 days
change in disposition index
Measured: 14 days
self-report of history of symptoms of anemia or gastrointestinal symptoms during study
Measured: 14 days
change in serum zinc
Measured: 14 days
change in urinary zinc
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Alan Shuldiner, University of Maryland, Baltimore
- Investigators
- Alan R Shuldiner, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981448
- Sponsor's protocol ID
- HP-00040355
- Other IDs
- 1KL2RR025006-01
- Status last verified
- Jan 2022
- First submitted
- 18 Sep 2009
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25348609
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
- ClinicalTrials.gov ID
- NCT00981448
- Acronym / sponsor ID
- HP-00040355
- Conditions
- Diabetes
- Keywords
- zinc, diabetes, genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Sep 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zinc supplement | Experimental | Dietary Supplement: Zinc acetate |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 21-70 years
- Amish decent
- genotyping of rs13266634 of SLC30A8 gene
- previously consented to contact for future studies and future use of DNA
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc acetateAlso: Orazinc50mg of elemental zinc to be administered 2 times daily orally for 14 days. | Dietary supplement | Zinc supplement |
Primary outcome
Change in acute insulin response from IVGTT.
Time frame: 14 days
5 secondary outcomes
change in insulin sensitivity
Time frame: 14 days
change in disposition index
Time frame: 14 days
self-report of history of symptoms of anemia or gastrointestinal symptoms during study
Time frame: 14 days
change in serum zinc
Time frame: 14 days
change in urinary zinc
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 25348609Maruthur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan R Shuldiner, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc acetate in people with Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute insulin response from IVGTT. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.