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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK092926 | U.S. NIH Grant/Contract | View source | |
| K01DK107456 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
Polycystic ovary syndrome (PCOS) is a common and costly ($4.3 billion/year) endocrine disorder that significantly impairs quality of life and increases the risk of obesity and type 2 diabetes as well as hyperandrogenism, infertility, hyperlipidemia, and cardiovascular disease. Diet and lifestyle weight-loss interventions are recommended as the first-line treatment of PCOS, but experts disagree about which nutritional approach is best. A review of previous diet and lifestyle trials in PCOS did find a slight benefit of lower carbohydrate diets for weight loss, glucose control, insulin, and insulin resistance. This may be because carbohydrate intake leads to increased insulin secretion, which then stimulates ovarian androgen production and inhibits the release of fatty acids from cells, both of which worsen PCOS-related issues. Although lower carbohydrate diets may be helpful, research from other populations with or at risk of type 2 diabetes suggests that prior PCOS studies may have set insufficient carbohydrate reduction targets. The investigators propose that a very-low carbohydrate diet may be needed to especially benefit women with PCOS, as greater carbohydrate reduction should have a larger impact on androgen levels and weight loss. Thus, the goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| complete diet and lifestyle program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet and lifestyle program | Behavioral | Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Body Weight Loss | Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change | percentage of glycosylated hemoglobin | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
Inclusion Criteria:
We will include women in one PCOS subtype, those having these two symptoms:
Participants must also be:
Exclusion Criteria:
Participant eligibility is based on sex.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34934978 | Derived | Missel AL, O'Brien AV, Maser H, Kanwal A, Bayandorian H, Martin S, Carrigan P, McNamee R, Daubenmier J, Isaman DJM, Padmanabhan V, Smith YR, Aikens JE, Saslow LR. Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study. F S Rep. 2021 Sep 4;2(4):386-395. doi: 10.1016/j.xfre.2021.08.008. eCollection 2021 Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Complete Diet and Lifestyle Program | diet and lifestyle program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all participants at baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Complete Diet and Lifestyle Program | diet and lifestyle program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Body Weight Loss | Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100. | Posted | Mean | Standard Deviation | percentage of weight | 4 months |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Complete Diet and Lifestyle Program | diet and lifestyle program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| kidney stones | Renal and urinary disorders | Non-systematic Assessment | Two participants developed kidney stones, one within 2 weeks of starting the intervention and the other 2 months into the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Saslow | University of Michigan | (734) 764-7836 | saslowl@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2019 | Sep 18, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2019 | Sep 18, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. Behavioral: positive affect informational materials. They will also be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths, in addition to information about mindfulness and mindful eating techniques.
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Laboratory results will be assessed by a lab not associated with the study team.
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|
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | 4 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | HbA1c Change | percentage of glycosylated hemoglobin | Posted | Mean | Standard Deviation | units of % | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| Other Pre-specified | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability | Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
|
| blurry vision | Eye disorders | Non-systematic Assessment | A participant reported continuous muscle cramping and blurry vision 2 months into the intervention; symptoms subsided after consulting with their physician. |
|
| muscle cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment | A participant reported continuous muscle cramping and blurry vision 2 months into the intervention; symptoms subsided after consulting with their physician. |
|
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |