Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Free Islamic University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00429390
First received: January 29, 2007
Last updated: January 30, 2007
Last verified: January 2007

January 29, 2007
January 30, 2007
August 2006
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Measuring insulin sensitivity in metabolic syndrome
Same as current
Complete list of historical versions of study NCT00429390 on ClinicalTrials.gov Archive Site
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Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome
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this study was conducted to assess the insulin resistance indices in the subjects undergoing Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days period.

Insulin resistance is a feature of a number of clinical disorders, including type 2 diabetes/glucose intolerance, obesity, dyslipidaemia and hypertension clustering in the so-called metabolic syndrome.The prevalence of the metabolic syndrome, as defined by the 2001 ATP III criteria, was 22 percent, with an age-dependent increase.Data demonstrates that the prevalence has continued to increase, particularly in women.Hyperinsulinemia occurring in response to insulin resistance may play an important role in the genesis of metabolic syndrome. Prevention or reduction of obesity, particularly abdominal obesity, is the main therapeutic goal in patients with the metabolic syndrome .Weight reduction is optimally achieved with a multimodality approach including diet, exercise, and possible pharmacologic therapy, as with orlistat .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, by reducing insulin resistance may be effective in improving the metabolic syndrome .During the month of Ramadan (The ninth month of the Islamic calendar), Muslims fast every day from dawn to sunset. They refrain from drinking and eating for about 12h intervals. There are currently no reports on the effect of Ramadan fasting (only two meals per day) on metabolic syndrome. Therefore, this study was conducted to assess the insulin resistance indices in the subjects undergoing this type of fasting for a thirty days period.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
Behavioral: Ramadan Fasting
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
November 2006
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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
Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00429390
1345103
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Free Islamic University of Medical Sciences
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Principal Investigator: Zahra V Shariatpanahi, MD Islamic Free University of Medical Science
Free Islamic University of Medical Sciences
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP