The effect of levothyroxine treatment on glucose metabolism in patients with hypothyroidism
Design
Non randomized clinical trial, without control group, before and after exposure assessment
Settings and conduct
This clinical trial include samples who are newly diagnosed with hypothyroidism and who have indications of levothyroxine therapy referred to the endocrinology clinic of Tabriz Imam Reza Hospital. The total sample size is 40. Fasting serum insulin and glucose levels and lipid profiles in all participants will be assessed at baseline and three months after levothyroxine treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria: All newly diagnosed hypothyroidism needs treatment in the age range of 18 to 65 years
exclusion criteria: Patients with diabetes mellitus, hypertension, heart failure, liver and kidney disease and polycystic ovary syndrome, treatment with levothyroxine, statins and OCPs in the last 3 months, pregnancy and lactation
Intervention groups
Patients with hypothyroidism requires treatment in the age range of 18 to 65 years
Main outcome variables
Body Mass Index; Thyroid Function Tests; Insulin Resistance; Lipid Profile; Anti TPO Ab Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130610013612N10
Registration date:2019-09-02, 1398/06/11
Registration timing:registered_while_recruiting
Last update:2019-09-02, 1398/06/11
Update count:0
Registration date
2019-09-02, 1398/06/11
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-01, 1398/05/10
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of levothyroxine on glucose metabolism in hypothyroid patients aged 18-65 years
Public title
effects of levothyroxin on glucose metabolism in patients with hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All newly diagnosed hypothyroidism require treatment in the age range of 18 to 65 years
Exclusion criteria:
Patients with diabetes mellitus, hypertension, heart failure, liver and kidney disease and polycystic ovary syndrome
Treatment with levothyroxine, statins and OCPs in the last 3 months
Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
کمیته محترم اخلاق دانشگاه علوم پزشکی تبریز
Street address
Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street , Tabriz