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Register:	ISRCTN
Last refreshed on:	19 December 2016
Main ID:	ISRCTN10447746
Date of registration:	22/11/2016
Prospective Registration:	No
Primary sponsor:	Ain-Shams University Research Ethical committee
Public title:	Insulin resistance in type 1 diabetes
Scientific title:	Effect of metformin therapy on serum fetuin levels in insulin resistant type 1 diabetics
Date of first enrolment:	01/03/2013
Target sample size:	40
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN10447746
Study type:	Interventional
Study design:	Single-arm prospective open label interventional study (Other)
Phase:

Countries of recruitment
Egypt

Contacts

Name:	Yara Eid
Address:	Ain Shams University - Faculty of Medicine , Ramsis street - abbassia square 11591 Cairo Egypt
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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria: T1DM male subjects = 18 years of age
Exclusion criteria: Subjects with other chronic diseases (such as end-stage liver disease and end-stage renal disease), collagen diseases, malignancies and subjects with any other endocrinopathy (e.g. Cushing’s syndrome and acromegaly) or taking any medications (e.g. thiazide diuretics or steroids) that may affect insulin resistance.

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Type 1 diabetes
Nutritional, Metabolic, Endocrine
Insulin-dependent diabetes mellitus

Intervention(s)

Type 1 patients eligible for the study were screened for insulin resistance. Subjects with documented insulin resistance were given 1mg metformin twice daily for three months as an add-on to their insulin regimen. Parameters were assessed before intervention and directly at the end of 3 months.

These parameters included:
1. Demographic: BMI , blood pressure ,waist circumference , waist /hip ratio, insulin units /kg , the method of assessment is physical examination and history taking at the basal visit prior to intervention and after 3 months of intervention.
2. Laboratory: Fasting , 2-hour postprandial blood glucose level , glycated-hemoglobin percent (HbA1c) % ,lipid profile: total cholesterol, TG, HDL, LDL , highly sensitive CRP (hs-CRP), measurement of serum fetuin level and calculation of estimated glucose disposal rate.

There was no control arm as all patients with insulin resistance received the same intervention and the outcomes were observed.

Primary Outcome(s)

Effect of metformin therapy on fetuin level in insulin resistant type 1 diabetics

Assessed before assessed before intervention and again at 3 months.

Secondary Outcome(s)

1. Effect of metformin therapy on insulin resistance surrogate (eGDR)
2. Glycemic control (HbA1c%)
3. BMI
4. Weight
5. Insulin dose
6. HsCRP as a marker of cardiovascular risk

All assessed before assessed before intervention and again at 3 months.

Secondary ID(s)

1491

Source(s) of Monetary Support

Investigator initiated and funded

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
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