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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429390
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : January 31, 2007
Information provided by:
Free Islamic University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Ramadan Fasting Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Measuring insulin sensitivity in metabolic syndrome

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429390

Sponsors and Collaborators
Free Islamic University of Medical Sciences
Principal Investigator: Zahra V Shariatpanahi, MD Islamic Free University of Medical Science Identifier: NCT00429390     History of Changes
Other Study ID Numbers: 1345103
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: January 31, 2007
Last Verified: January 2007

Keywords provided by Free Islamic University of Medical Sciences:
Metabolic syndrome
Ramadan Fasting
Insulin sensitivity

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases