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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Ramadan Fasting

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Ramadan Fasting, Insulin sensitivity, Iran

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Measuring insulin sensitivity in metabolic syndrome

Secondary Outcome Measures

Full Information

NCT ID

NCT00429390

First Posted

January 29, 2007

Last Updated

January 30, 2007

Sponsor

Free Islamic University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00429390

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Free Islamic University of Medical Sciences

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic syndrome, Ramadan Fasting, Insulin sensitivity, Iran

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Ramadan Fasting

Primary Outcome Measure Information:

Title

Measuring insulin sensitivity in metabolic syndrome

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zahra V Shariatpanahi, MD

Organizational Affiliation

Islamic Free University of Medical Science

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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