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The effect of vitamin k1 in diabetic patient treatment

Phase 2
Conditions
prediabetes.
Abnormal glucose tolerance test
Registration Number
IRCT2013120915724N1
Lead Sponsor
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz Jundishapur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
84
Inclusion Criteria

Willingness to participate in the study and sign the Written informed consent; Age between 22 to 45 years old; BMI=25-29.9 kg/m2; 100 =FBS=126 or 140 =2hpp=200 mg/dL
Exclusion criteria: Heart, Kidney, liver and Rheumatoid diseases; Osteoporosis; Hyperthyroidism and Thyroid dysfunction; Pregnancy; Lactation; Menopause; Intake of insulin and glucose and lipid-lowering Agents; Warfarin; Corticosteroids; drugs to treat osteoporosis; Vitamin and Mineral supplements during past 6 months.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum carboxylated osteocalcin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;Serum carboxylated osteocalcin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;Serum total osteocalcin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;Serum Hb A1C. Timepoint: Baseline and after 4 weeks. Method of measurement: HPLC assay.;Total energy and nutrient intaake. Timepoint: Baseline, middle and 4th weeks. Method of measurement: 24 hour recall.
Secondary Outcome Measures
NameTimeMethod
Fasting and 2 hour serum insulin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;Fasting and 2 hour serum glucose. Timepoint: Baseline and after 4 weeks. Method of measurement: calorimetric assay.;HOMA-IR. Timepoint: Baseline and after 4 weeks. Method of measurement: formula.;HOMA-%B. Timepoint: Baseline and after 4 weeks. Method of measurement: formula.;ISI. Timepoint: Baseline and after 4 weeks. Method of measurement: formula.;Serum adiponectin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;Serum leptin. Timepoint: Baseline and after 4 weeks. Method of measurement: ELISA assay.;BMI. Timepoint: Baseline and after 4 weeks. Method of measurement: formula.;Waist to hip ratio. Timepoint: Baseline and after 4 weeks. Method of measurement: formula.;Bady fat. Timepoint: Baseline and after 4 weeks. Method of measurement: OMRON.
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