NCT03112382

Brief Summary

Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

April 4, 2017

Last Update Submit

August 6, 2017

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (2)

  • SLC30A8 rs13266634 polymorphism

    genetic screening of SLC30A8 : solute carrier family 30 member 8

    one year

  • serum zinc

    at base line

Secondary Outcomes (9)

  • change from baseline in fasting and 2hr post prandial blood glucose at three months

    at base line and after three months

  • change from baseline in HbA1c at three months

    base line and three months

  • change from baseline in lipid profile at three months

    base line and three months

  • change from baseline in fasting serum insulin at three months

    baseline and three months

  • change from baseline in ALT level at three months

    baseline and three months

  • +4 more secondary outcomes

Study Arms (3)

zinc supplement plus vitamin A and E

ACTIVE COMPARATOR

patients will be receiving zinc supplement plus vitamin A and E for 3 months.

Drug: zinc supplement plus vitamin A and E

vitamin A and E

ACTIVE COMPARATOR

patients will be receiving equivalent dose of vitamin A and E only for 3 months

Drug: vitamin A and E

no vitamins

NO INTERVENTION

patients will be observed for 3 months

Interventions

zinc supplement plus vitamin A and EDRUG
zinc supplement plus vitamin A and E
vitamin A and EDRUG
vitamin A and E

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Established diagnosis of type 2 diabetes mellitus.
  • Age between 20 and 64 years.
  • BMI \< 40 kg/m2.
  • On fixed oral hypoglycemic dosage for at least 3 months.
  • Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
  • Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).

You may not qualify if:

  • Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
  • Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
  • Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
  • Pregnant or intend to be pregnant for t least 3 months or lactating women.
  • Those who were receiving insulin preparations as a part of diabetes management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vitamin Avitamin A, vitamin E drug combination

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

EG(1)