HyperandrogenismM-PCOSNCT01569425
Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
A study testing Dietary intervention in people with Hyperandrogenism and Insulin Resistance, run by Tel Aviv University at 1 site in Israel.
Trial summary
In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hyperandrogenism, Insulin Resistance
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Jun 2015
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects ≥18 and ≤45 years of age
- Lean women with PCOS (BMI: ≤ 25 kg/m2)
- Signed informed consent
- Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl.
- Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC).
- Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
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- Stable physical activity pattern during the three months immediately preceding study initiation
- Hyperandrogenemia (elevated free testosterone).
- Normal liver and kidney function
- Fasting blood glucose <110 mg/dl.
- No metabolic disease
- Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
- Normal TSH and FT4 levels and serum prolactin
- Acceptable health based on interview, medical history, physical examination, and laboratory tests
Who cannot join
- Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer).
- Current use of oral contraceptives
- Serum creatinine level > 1.5 mg/dl
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
- Any physiologic or mechanical problems preventing dietary adherence
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- Pregnant or lactating
- Participating in another dietary program or use of weight-loss medications
- Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
- Use of psychotropic or anoretic medication during the month immediately prior to study onset
- Night or rotating shift work
- Jet lag during the 2 week period immediately prior to study onset
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.
Read the detailed description
Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism.
In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism.
We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS.
Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.
- Conditions
- Hyperandrogenism, Insulin Resistance
- Being tested
- Dietary intervention
- Keywords
- PCOS
- Medical subject headings
- Hyperandrogenism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
High Calorie breakfast and high calorie dinner
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Lifestyle counseling, with high calorie breakfast Receives: Other: Dietary intervention |
| Life Counseling | Active comparator | Diet with high calorie dinner Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperandrogenism
Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution
Measured: 90 days
Secondary outcomes (1)
glucose metabolism
Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Diabetes Unit E. Wolfson Medical Center Tel Aviv UniversityMona Boaz, PhD, Study director, E. Wolfson Medical Center Tel Aviv UniversityJulio Wainstein, MD, Study chair, E. Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569425
- Sponsor's protocol ID
- 0048-12-WOMC
- Acronym
- M-PCOS
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01569425
- Acronym / sponsor ID
- M-PCOS / 0048-12-WOMC
- Conditions
- Hyperandrogenism, Insulin Resistance
- Keywords
- PCOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 3 Apr 2012 (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.
In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.
Detailed description
Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism.
In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism.
We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS.
Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Other: Dietary interventionLifestyle counseling, with high calorie breakfast |
| Life Counseling | Active comparator | Other: Dietary interventionDiet with high calorie dinner |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subjects ≥18 and ≤45 years of age
- Lean women with PCOS (BMI: ≤ 25 kg/m2)
- Signed informed consent
- Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl.
- Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC).
Key exclusion criteria (13 listed)
- Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer).
- Current use of oral contraceptives
- Serum creatinine level > 1.5 mg/dl
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
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 |
|---|---|---|
| Dietary interventionHigh Calorie breakfast and high calorie dinner | Other | Life Counseling, Lifestyle counseling |
Primary outcome
hyperandrogenism
Time frame: 90 days
Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution
1 secondary outcome
glucose metabolism
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
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Polycystic Ovarian Syndrome (PCOS)
Not yet recruitingObservational study
Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
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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.
Daniela Jakubowicz, MD principal investigator
Diabetes Unit E. Wolfson Medical Center Tel Aviv University
Mona Boaz, PhD study director
E. Wolfson Medical Center Tel Aviv University
Julio Wainstein, MD study chair
E. Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Hyperandrogenism and Insulin Resistance, run by Tel Aviv University at 1 site in Israel.
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 14 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
hyperandrogenism (time frame: 90 days). 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 8 Apr 2015.