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Report for Clinical Trial NCT01328210

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial

Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a recommended treatment for subjects with obesity and vascular disease. Recent studies showed that blood letting with iron depletion may improve insulin sensitivity in patients with diabetes mellitus. The investigators aimed to test if traditional blood letting has beneficial effects in patients with MS. A randomized trial with a sample size of 64 self-referred MS patients was conducted. Patients in the blood letting group were allocated to blood letting intervention and the control group was offered a later treatment (waiting list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin sensitivity as measured by HOMA-Index.

NCT01328210 Metabolic Syndrome
MeSH:Metabolic Syndrome Syndrome

1 Interventions

Name: blood letting

Description: blood letting twice within 4 weeks. First blood removal baseline with 400ml of venous blood and second blood removal with 300-400ml according to serum ferritin levels.
Type: Procedure
Group Labels: 1

blood letting


Primary Outcomes

Description: Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index

Measure: insulin sensitivity

Time: change from baseline at 6 weeks

Description: Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry

Measure: systolic blood pressure

Time: change from baseline at 6 weeks

Secondary Outcomes

Measure: diastolic blood pressure

Time: change from baseline at 6 weeks

Measure: HbA1c

Time: change from baseline at 6 weeks

Measure: blood lipids

Time: change from baseline at 6 weeks

Measure: serum ferritin

Time: change from baseline at 6 weeks

Measure: adiponectin

Time: change from baseline at 6 weeks

Measure: blood count

Time: change from baseline at 6 weeks

Measure: serum iron

Time: change from baseline at 6 weeks

Measure: hs-CRP

Time: change from baseline at 6 weeks

Measure: pulse rate

Time: change from baseline at 6 weeks

Measure: serum glucose

Time: change from baseline at 6 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 C282Y

Inclusion Criteria: - 25-70 years of age - given diagnosis of metabolic syndrome Exclusion Criteria: - clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy - known history of hemochromatosis, or presence of the Cys282Tyr mutation - history of drug or alcohol abuse - manifest cardiac disease - history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia) - preexisting anemia Inclusion Criteria: - 25-70 years of age - given diagnosis of metabolic syndrome Exclusion Criteria: - clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy - known history of hemochromatosis, or presence of the Cys282Tyr mutation - history of drug or alcohol abuse - manifest cardiac disease - history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia) - preexisting anemia Metabolic Syndrome Metabolic Syndrome Syndrome null --- Cys282Tyr ---

Inclusion Criteria: - 25-70 years of age - given diagnosis of metabolic syndrome Exclusion Criteria: - clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy - known history of hemochromatosis, or presence of the Cys282Tyr mutation - history of drug or alcohol abuse - manifest cardiac disease - history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia) - preexisting anemia Inclusion Criteria: - 25-70 years of age - given diagnosis of metabolic syndrome Exclusion Criteria: - clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy - known history of hemochromatosis, or presence of the Cys282Tyr mutation - history of drug or alcohol abuse - manifest cardiac disease - history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia) - preexisting anemia Metabolic Syndrome Metabolic Syndrome Syndrome null --- Cys282Tyr --- --- Cys282Tyr ---



HPO Nodes