Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
Metabolic Syndrome
Behavioral: Ramadan Fasting

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

Resource links provided by NLM:


Further study details as provided by Free Islamic University of Medical Sciences:

Primary Outcome Measures:
  • Measuring insulin sensitivity in metabolic syndrome

Estimated Enrollment: 55
Study Start Date: August 2006
Estimated Study Completion Date: November 2006
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429390

Sponsors and Collaborators
Free Islamic University of Medical Sciences
Investigators
Principal Investigator: Zahra V Shariatpanahi, MD Islamic Free University of Medical Science
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429390     History of Changes
Other Study ID Numbers: 1345103
Study First Received: January 29, 2007
Last Updated: January 30, 2007
Health Authority: Iran: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014