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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.
Obesity has a greater detrimental impact on the health of African American women (AAW) than on any other racial or gender group. Nearly 80% of AAW are overweight or obese. Reduced insulin sensitivity is more prevalent among AAW as compared to white women and men of both races. This condition puts AAW at increased risk for the development of type 2 diabetes mellitus. The exact mechanism underlying these pathophysiological differences remains unknown. The investigators have found that obese AAW have decreased parasympathetic nerve (PNS) activity compared to whites and recent studies in animal models showed that the PNS confers protection against oxidative stress. In our AA cohort, PNS activity was directly correlated with insulin sensitivity in obese AAW even after controlling for differences in age, blood pressure and visceral adiposity. Equally important, the investigators also showed that the decrease in insulin sensitivity was associated with increased oxidative stress as measured by plasma levels of F2-isoprostanes. Taken together these findings lead us to hypothesize that the decreased PNS activity in obese AAW compared to white women has deleterious effects on oxidative stress and insulin sensitivity.The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galantamine 16 mg then placebo | Experimental | Galantamine 16 mg po one time dose then placebo on 2nd visit |
|
| Placebo then Galantamine 16 mg | Placebo Comparator | Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug | 16 mg po prior to the infusion of intralipid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidative Stress: Baseline to 2 Hours | Measure F-2 isoprostanes as a marker of oxidation | Baseline to 2 hours |
| Change in Oxidative Stress: Baseline to 4 Hours | Measure F-2 isoprostanes as a marker of oxidation | Baseline to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyndya Shibao, MD | Vanderbilt University Medical Center, Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35659521 | Derived | Parsa D, Aden LA, Pitzer A, Ding T, Yu C, Diedrich A, Milne GL, Kirabo A, Shibao CA. Enhanced parasympathetic cholinergic activity with galantamine inhibited lipid-induced oxidative stress in obese African Americans. Mol Med. 2022 Jun 3;28(1):60. doi: 10.1186/s10020-022-00486-5. |
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52 participants were screen failures and did not receive an intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galantamine 16 mg Then Placebo (African-American) | Galantamine 16 mg po one time dose then placebo on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| FG001 | Galantamine 16 mg Then Placebo (White) | Galantamine 16 mg po one time dose then placebo on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| FG002 | Placebo Then Galantamine 16 mg (African-American) | Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| FG003 | Placebo Then Galantamine 16 mg (White) | Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Galantamine 16 mg Then Placebo (African-American) | Galantamine 16 mg po one time dose then placebo on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Oxidative Stress: Baseline to 2 Hours | Measure F-2 isoprostanes as a marker of oxidation | 2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision. | Posted | Mean | Standard Deviation | pg /ml | Baseline to 2 hours |
|
Baseline through 2nd study day, usually about 1 month.
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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 | Galantamine 16 mg (African-American) | Galantamine 16 mg po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cyndya Shibao, MD | Vanderbilt University Medical Center | 615-322-2318 | cyndya.shibao@vumc.org |
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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 | Jun 5, 2017 | Feb 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| C545823 | soybean oil, phospholipid emulsion |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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| Placebo Oral Capsule | Drug | Placebo oral capsule prior to the infusion of intralipid/heparin |
|
| Intralipid | Drug | Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine |
|
|
| Heparin | Drug | heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
|
| Adverse Event |
|
| Galantamine 16 mg Then Placebo (White) |
Galantamine 16 mg po one time dose then placebo on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| BG002 | Placebo Then Galantamine 16 mg (African-American) | Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| BG003 | Placebo Then Galantamine 16 mg (White) | Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo (African-American) | Placebo capsule po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
| OG003 | Placebo (White) | Placebo capsule po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine |
|
|
| Primary | Change in Oxidative Stress: Baseline to 4 Hours | Measure F-2 isoprostanes as a marker of oxidation | 1 white participant did not have 4 hour F-2 isoprostanes drawn after receiving placebo. 2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision. | Posted | Mean | Standard Deviation | pg/ml | Baseline to 4 hours |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Galantamine 16 mg (White) | Galantamine 16 mg po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine | 0 | 9 | 0 | 9 | 6 | 9 |
| EG002 | Placebo (African-American) | Placebo capsule po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine | 0 | 14 | 0 | 14 | 2 | 14 |
| EG003 | Placebo (White) | Placebo capsule po one time dose Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine | 0 | 9 | 0 | 9 | 2 | 9 |
| Lightheadness | General disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |