The effect of iron deficiency treatment on insulin resistance in women with type 2 diabetes and iron deficiency anemia
Design
Clinical trial, single group, before after study
Settings and conduct
The study will be conducted on women with type 2 diabetes and iron deficiency anemia, at the Shahid Beheshti Hospital, Qom. The outcomes associated with diabetes control (including Insulin resistance, Hemoglobin A1C and serum cholesterol), will be evaluated, before and after treatment of iron deficiency in 40 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Woman who has been diagnosed with type 2 diabetes more than one year, Age 30-50 years, Iron deficiency anemia with hemoglobin <12;
Exclusion criteria: Insulin therapy, Polymenorrhea, Pregnancy, Breast-feeding
Intervention groups
Intervention group: Administration of Ferrous sulfate tablet of Rouzdarou pharmaceutical co, with dosage of 325 mg, taken orally, daily, for 6 months
Main outcome variables
Insulin resistance; Hemoglobin A1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170215032587N3
Registration date:2018-07-22, 1397/04/31
Registration timing:registered_while_recruiting
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Mohammad Aghaali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 751 5639
Email address
maghaali@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iron deficiency treatment on insulin resistance in women with type 2 diabetes and iron deficiency anemia
Public title
The effect of iron deficiency treatment on insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than one year has passed since the diagnosis of type 2 diabetes
Age 30-50 years
Iron deficiency anemia with hemoglobin less than 12
Exclusion criteria:
Insulin therapy
Polymenorrhea
Chronic diarrhea
History of gastrectomy
CRP above 10 mg/L
Pregnancy
Breast-feeding
Age
From 30 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences