Metabolic Syndrome and Inflammatory Markers

Metabolic Syndrome Clinical Trial

Official title:

Effect of Fasting With Two Meals on Inflammatory Markers of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433082
• Other study ID #: 1345104
• Status: Completed
• Phase: N/A
• First received: February 8, 2007
• Last updated: February 8, 2007
• Start date: August 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2007
• Source: Free Islamic University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, may be effective in improving the metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Males with metabolic syndrome

Exclusion Criteria:

• Conditions with insulin resistance including;

• Type 2 diabetes mellitus,

• Infections,

• Stresses,

• Uremia,

• Acromegaly,

• Glucocorticoid excess,

• Hypertension ,

• Cirrhosis and

• Any addiction or drug therapy and conditions witch cause changes in hs-CRP and fibrinogen levels including infection, trauma, infarction, inflammatory arthritis, various neoplasm and liver diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Ramadan Fasting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Free Islamic University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring inflammatory markers in metabolic syndrome