This double blind randomized controlled clinical trial study was designed to investigate the effects of zinc supplementation on serum adiponectin level and insulin resistance in patients with type II diabetes mellitus compared with the control group. Total of 60 patients aged between 30 to 50 years taking antidiabetic drugs, such as Metformin or Glibenclamid, are selected from Kashan Diabetic Center, and are randomly allocated into equal groups of placebo and zinc. One group will receive 30 mg zinc gluconate daily and other receive the same tablets as placebo for 12 weeks. Diets, exercise level and medications dosage will be held constant throughout the study. After obtaining the informed consent, subjects will be assessed by dietary intake, anthropometric, clinical and medical history, and biochemical measurements at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811013128N1
Registration date:2010-11-13, 1389/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-13, 1389/08/22
Registrant information
Name
Somayyeh Asghari mahiabadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 1253 0338
Email address
sasghari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-03-16, 1388/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of zinc supplementation on serum adiponectin level and insulin resistance in patients with type II diabetes mellitus
Public title
The effects of zinc supplementation on serum adiponectin level and insulin resistance in patients with type II diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30 to 50 years, presence of type 2 diabetes at least for one year, willingness to participate in the study and sign the informed consent, BMI=25-30, HbA1C≤8.5, Blood pressure ≤135/85 mmHg. Exclusion criteria: severe kidney, heart, liver, GI, pulmonary and infectious diseases, thyroid dysfunction, active cancer, previous myocardial infarction, recent surgery, Insulin therapy, changing in dose of medications such as oral anti-diabetic, anti-lipidemic and anti-hypertensive drugs 3 month before and during the study, consumption of vitamin-mineral supplements 6 month before and during the study, consumption of non-steroidal anti inflammatory drugs, glucocorticoids, hormonal drugs, antidepressants, psychotropic medications, antibiotics, dioretics, three months prior to study, Following weight-reducing diet 3 months before and during the study, smoking, pregnancy, breast feeding, postmenopausal women.
Age
From 30 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrinology & Metabolism Research Center
Street address
Shariati hospital,Tehran University of Medical Sciences