Metabolic SyndromeNCT00429390
Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome
A study testing Ramadan Fasting in people with Metabolic Syndrome, run by Free Islamic University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Ramadan Fasting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males with metabolic syndrome
Who cannot join
- Conditions with insulin resistance including:
- Type 2 diabetes mellitus
- Infections
- Stresses
- Uremia
- Acromegaly
Show all 10Show fewer
- Glucocorticoid excess
- Hypertension
- Cirrhosis and;
- Any addiction or drug therapy
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Ramadan Fasting
- Keywords
- Metabolic syndrome, Ramadan Fasting, Insulin sensitivity, Iran
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramadan FastingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring insulin sensitivity in metabolic syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startAug 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- Free Islamic University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Zahra V Shariatpanahi, MD, Principal investigator, Islamic Free University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429390
- Sponsor's protocol ID
- 1345103
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 31 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00429390
- Acronym / sponsor ID
- 1345103
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Ramadan Fasting, Insulin sensitivity, Iran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- Free Islamic University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Nov 2006
- First posted
- 31 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Males with metabolic syndrome
Key exclusion criteria (10 listed)
- Type 2 diabetes mellitus
- Infections
- Stresses
- Uremia
- Acromegaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramadan Fasting | Behavioural | – |
Primary outcome
Measuring insulin sensitivity in metabolic syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra V Shariatpanahi, MD principal investigator
Islamic Free University of Medical Science
Questions about this trial
What is this clinical trial studying?
A study testing Ramadan Fasting in people with Metabolic Syndrome, run by Free Islamic University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring insulin sensitivity in metabolic syndrome. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2007.