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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Medical scientists have found that people with diabetes who take the drug Metformin have less age-related disease than those taking other treatments and researchers believe it may prevent numerous diseases and conditions that effect older people. In addition, metformin extends lifespan in some animal models of human disease. The purpose of this study is to see if taking Metformin causes changes in blood cells consistent with improved health and longevity in people who do not have diabetes. In this study Metformin will be compared to placebo. A placebo is a substance, like a sugar pill, that is not thought to have any effect on a participants disease or condition. In this study participants will either receive the active study medication, Metformin or placebo which is not active. Placebos are used in research studies to see if the drug being studied really does have an effect.
The number of older adults is projected to increase dramatically by 2050. Aging-related diseases and conditions still seriously compromise the quality of life among most older adults. Several pharmaceutical agents, such as metformin, have been tested to extend lifespan and delay aging-related diseases and dysfunctions in mice. Metformin, a biguanide antidiabetic drug, reduces the risk for developing type-2 diabetes in persons at risk by over one-third with few adverse effects (e.g., gastrointestinal irritation). Metformin prevents type-2 diabetes primarily through decreasing hepatic glucose synthesis, as well as enhancing insulin sensitivity and increasing peripheral glucose uptake. The molecular mechanisms remain unclear, although a number of potential mechanism such as activation of AMP-activated protein kinase (AMPK) and inhibition of mitochondrial glycerophosphate dehydrogenase have been proposed. The fact that metformin treatment in persons with type-2 diabetes has been associated with reduced risk of other aging-related diseases and conditions, including cardiovascular disease, cancer and cognitive decline supports the possibility of the beneficial effects of metformin on healthy aging. It is imperative to capitalize on these leads to extend health span among older adults.
To translate animal findings to human intervention trials, appropriate aging biomarkers are needed. Methylomic and transcriptomic profiles in relevant cells may reflect molecular features that mediate effects of both genetic and environmental factors on aging-related functional decline and disease. The roles of monocytes have been implicated in development of many aging-related diseases such as cardiovascular disease, cancer and neurodegenerative disease. In a cross-sectional association study of 1,200 monocyte samples, we identified 1,794 age-associated methylation sites and 2,704 age-associated transcripts, which were over-represented in two networks (autophagy and oxidative phosphorylation) and suggestive of decline in those functions with age. Both autophagy and oxidative phosphorylation are considered as key contributors to the aging process, and their dysfunctions have been linked to aging-related diseases. Changes in these aging-related omic biomarkers may be early indicators of cellular damage or disruption that eventually leads to age-related dysfunctions. Assessment of these aging biomarkers in response to therapeutic intervention may also provide molecular insight for personalizing treatment. The investigators propose a pilot study to examine changes in aging-related omic profiles after 3 months of metformin treatment in 35 monocyte samples from older adults using a randomized, double-blind, placebo-controlled crossover study design.
Our overarching goal of the pilot study is to evaluate the utility of using the aging-related omic biomarkers as an indicator of pharmacologic responses in the anti-aging therapeutic intervention trials through the following specific aims. Although this pilot study does not have sufficient power to definitively test all the aims, it will provide essential preliminary data for developing a full scale research program.
A randomized, double-blind, placebo-controlled crossover trial in 30 participants using metformin and matching placebo will be used. In the absence of a treatment by sequence interaction effect, this design can increase study power for evaluating treatment effects by allowing each participant to be his/her own control. The period effect may be minimum because the primary outcomes, methylation and transcriptional measures, are relatively stable overtime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin then Placebo | Active Comparator | Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo. |
|
| Placebo then Metormin | Placebo Comparator | Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eigengene Scores | Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay. | baseline through 12 weeks |
| Change in Eigengene Scores | Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay. | baseline through 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Measures--macroautophagy | Macroautophagy is a process of wrapping cellular components inside autophagosomes and delivering them to lysosomes for degradation. | baseline through 12 weeks, 12 weeks through 24 weeks |
| Functional Measures--microautophagy |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | Baseline through 12 weeks, 12 weeks through 24 weeks | |
| Change in Expanded Short Physical Performance Battery (eSPPB) | Score ranges from 0 (low physical function) to 12 (high physical function). |
Inclusion Criteria:
Must meet criteria from one or more of the following groups:
Group 1 (Can have 1 or 2 of these, but not all 3)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingzhong Ding, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Then Placebo | Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo. Metformin Placebo |
| FG001 | Placebo Then Metormin | Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm. Metformin Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
|
| |||||||||||||||||||||
| Second Intervention Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin Then Placebo | Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo. Metformin Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed. |
| 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 | Change in Eigengene Scores | Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay. | Numbers differ from baseline due to subject withdraw or lost to follow up | Posted | Mean | Standard Deviation | Eigen Score | baseline through 12 weeks |
|
Baseline through week 24
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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 | Metformin | Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal--Nausea/Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jingzhong Ding, PhD | Atrium Health Wake Forest Baptist | 336-713-8601 | jding@wakehealth.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 | Sep 4, 2018 | Apr 28, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2018 | Apr 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060825 | Cognitive Dysfunction |
| D056128 | Obesity, Abdominal |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
|
| Baseline through 12 weeks, 12 weeks through 24 weeks |
| Functional Measures--chaperone-mediated Autophagy | Baseline through 12 weeks, 12 weeks through 24 weeks |
| Mitochondria Function: Respiratory Control Ratio (RCR) | Baseline through 12 weeks, 12 weeks through 24 weeks |
| Mitochondria Function: State 3 (Maximal Oxygen Consumption Rate) | Baseline through 12 weeks, 12 weeks through 24 weeks |
| Mitochondria Function: State 4 (Oxygen Consumption Upon Inhibition of ATP Synthase) | Baseline through 12 weeks, 12 weeks through 24 weeks |
| From baseline through 12 weeks |
| Change in Expanded Short Physical Performance Battery (eSPPB) | Score ranges from 0 (low physical function) to 12 (high physical function). | From 12 weeks through 24 weeks |
| Nottingham Power Rig | The Nottingham power rig evaluates mean unilateral leg muscle power | Baseline through 12 weeks, 12 weeks through 24 weeks |
| Grip Strength | measurement of the amount of static force that the hand can squeeze | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Change in Montreal Cognitive Assessment (MoCA) | Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function). | Baseline through 12 weeks |
| Change in Montreal Cognitive Assessment (MoCA) | Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function). | 12 weeks through 24 weeks |
| Blood Lipids--total Cholesterol | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Blood Lipids--HDL-Cholesterol | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Blood Lipids--Triglycerides | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Blood Lipids--calculated LDL Levels | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Mobility Assessment Tool - Short Form (MAT-sf). | MAT-sf is a tool for assessing self-perception of mobility. The possible range of score is from 30 to 80 with lower score indicating lower perception of mobility. | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Pepper Assessment Tool for Disability (PAT-D) | The PAT-D is a self-administered questionnaire which consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons". | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Medication Adherence | Amount of medication expected to be taken vs. amount participant actually takes. | Baseline through 12 weeks and 12 weeks through 24 weeks |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG001 | Placebo Then Metormin | Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm. Metformin Placebo |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
| OG001 | Placebo Then Metormin | Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm. Metformin Placebo |
|
|
| Primary | Change in Eigengene Scores | Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay. | Numbers differ from baseline due to subject withdraw or lost to follow up | Posted | Mean | Standard Deviation | Eigen Score | baseline through 24 weeks |
|
|
|
| Secondary | Functional Measures--macroautophagy | Macroautophagy is a process of wrapping cellular components inside autophagosomes and delivering them to lysosomes for degradation. | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Secondary | Functional Measures--microautophagy | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | Baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Secondary | Functional Measures--chaperone-mediated Autophagy | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | Baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Secondary | Mitochondria Function: Respiratory Control Ratio (RCR) | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | Baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Secondary | Mitochondria Function: State 3 (Maximal Oxygen Consumption Rate) | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | Baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Secondary | Mitochondria Function: State 4 (Oxygen Consumption Upon Inhibition of ATP Synthase) | Unable to collect and analyze these measures due to lack of funding--samples were not collected. | Posted | Baseline through 12 weeks, 12 weeks through 24 weeks |
|
|
| Other Pre-specified | Vital Signs | Not Posted | Baseline through 12 weeks, 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Change in Expanded Short Physical Performance Battery (eSPPB) | Score ranges from 0 (low physical function) to 12 (high physical function). | Changes in population due to withdraw/loss to follow up | Posted | Mean | Standard Deviation | score on a scale | From baseline through 12 weeks |
|
|
|
| Other Pre-specified | Change in Expanded Short Physical Performance Battery (eSPPB) | Score ranges from 0 (low physical function) to 12 (high physical function). | Changes in population due to withdraw/loss to follow up | Posted | Mean | Standard Deviation | score on a scale | From 12 weeks through 24 weeks |
|
|
|
| Other Pre-specified | Nottingham Power Rig | The Nottingham power rig evaluates mean unilateral leg muscle power | Not Posted | Baseline through 12 weeks, 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Grip Strength | measurement of the amount of static force that the hand can squeeze | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Change in Montreal Cognitive Assessment (MoCA) | Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function). | Changes in participant numbers are due to due to withdraw/loss to follow up | Posted | Mean | Standard Deviation | score on a scale | Baseline through 12 weeks |
|
|
|
| Other Pre-specified | Change in Montreal Cognitive Assessment (MoCA) | Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function). | Changes in participant numbers are due to due to withdraw/loss to follow up | Posted | Mean | Standard Deviation | score on a scale | 12 weeks through 24 weeks |
|
|
|
| Other Pre-specified | Blood Lipids--total Cholesterol | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Blood Lipids--HDL-Cholesterol | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Blood Lipids--Triglycerides | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Blood Lipids--calculated LDL Levels | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Mobility Assessment Tool - Short Form (MAT-sf). | MAT-sf is a tool for assessing self-perception of mobility. The possible range of score is from 30 to 80 with lower score indicating lower perception of mobility. | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Pepper Assessment Tool for Disability (PAT-D) | The PAT-D is a self-administered questionnaire which consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons". | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| Other Pre-specified | Medication Adherence | Amount of medication expected to be taken vs. amount participant actually takes. | Not Posted | Baseline through 12 weeks and 12 weeks through 24 weeks | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 9 |
| 30 |
| EG001 | Placebo | Placebo will be given for 3 months. | 0 | 30 | 0 | 30 | 1 | 30 |
| Itching | General disorders | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | Non-systematic Assessment |
|
| Ataxia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|