Trial Outcomes & Findings for GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response (NCT NCT04387201)
NCT ID: NCT04387201
Last Updated: 2024-12-05
Results Overview
natural log transformed data is reported
COMPLETED
PHASE4
23 participants
6 weeks after start of each intervention
2024-12-05
Participant Flow
Participant milestones
| Measure |
Cyanocobalamin, Then Dulaglutide
Participants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
Dulaglutide, Then Cyanocobalamin
Participants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
17
|
6
|
|
First Intervention (6 Weeks)
Received Intervention
|
16
|
6
|
|
First Intervention (6 Weeks)
COMPLETED
|
12
|
6
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
5
|
0
|
|
Washout (3 Weeks)
STARTED
|
12
|
6
|
|
Washout (3 Weeks)
COMPLETED
|
12
|
6
|
|
Washout (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
12
|
6
|
|
Second Intervention (6 Weeks)
Received Intervention
|
12
|
6
|
|
Second Intervention (6 Weeks)
COMPLETED
|
11
|
4
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
Baseline characteristics by cohort
| Measure |
Cyanocobalamin, Then Dulaglutide
n=17 Participants
Participants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
Dulaglutide, Then Cyanocobalamin
n=6 Participants
Participants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 7 • n=5 Participants
|
39 years
STANDARD_DEVIATION 5 • n=7 Participants
|
39 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
6 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Body Mass Index
|
30.5 kilograms per square meter
STANDARD_DEVIATION 3.4 • n=5 Participants
|
31.4 kilograms per square meter
STANDARD_DEVIATION 2.8 • n=7 Participants
|
30.73 kilograms per square meter
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Systolic Blood Pressure
|
126 millimeters of mercury
STANDARD_DEVIATION 13 • n=5 Participants
|
118 millimeters of mercury
STANDARD_DEVIATION 11 • n=7 Participants
|
123 millimeters of mercury
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Diastolic Blood Pressure
|
79 millimeters of mercury
STANDARD_DEVIATION 6 • n=5 Participants
|
75 millimeters of mercury
STANDARD_DEVIATION 8 • n=7 Participants
|
77 millimeters of mercury
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Fasting Glucose Level
|
94 milligrams per deciliter
STANDARD_DEVIATION 16 • n=5 Participants
|
96 milligrams per deciliter
STANDARD_DEVIATION 14 • n=7 Participants
|
94 milligrams per deciliter
STANDARD_DEVIATION 15 • n=5 Participants
|
|
percentage of glycosylated hemoglobin
|
5.5 percentage of glycosylated hemoglobin"
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.7 percentage of glycosylated hemoglobin"
STANDARD_DEVIATION 0.1 • n=7 Participants
|
5.5 percentage of glycosylated hemoglobin"
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Triglycerides Level
|
135 milligrams per deciliter
STANDARD_DEVIATION 93 • n=5 Participants
|
124 milligrams per deciliter
STANDARD_DEVIATION 86 • n=7 Participants
|
132 milligrams per deciliter
STANDARD_DEVIATION 91 • n=5 Participants
|
|
Total Cholesterol Level
|
193 milligrams per deciliter
STANDARD_DEVIATION 38 • n=5 Participants
|
201 milligrams per deciliter
STANDARD_DEVIATION 31 • n=7 Participants
|
195 milligrams per deciliter
STANDARD_DEVIATION 36 • n=5 Participants
|
|
high-density lipoprotein (HDL) Cholesterol Level
|
56 milligrams per deciliter
STANDARD_DEVIATION 24 • n=5 Participants
|
55 milligrams per deciliter
STANDARD_DEVIATION 8 • n=7 Participants
|
55 milligrams per deciliter
STANDARD_DEVIATION 21 • n=5 Participants
|
|
low-density lipoprotein (LDL) Cholesterol Level
|
111 milligrams per deciliter
STANDARD_DEVIATION 35 • n=5 Participants
|
122 milligrams per deciliter
STANDARD_DEVIATION 28 • n=7 Participants
|
113 milligrams per deciliter
STANDARD_DEVIATION 33 • n=5 Participants
|
|
aspartate aminotransferase (AST) Level
|
22 units per liter
STANDARD_DEVIATION 8 • n=5 Participants
|
19 units per liter
STANDARD_DEVIATION 5 • n=7 Participants
|
21 units per liter
STANDARD_DEVIATION 7 • n=5 Participants
|
|
alanine aminotransferase (ALT) Level
|
24 units per liter
STANDARD_DEVIATION 14 • n=5 Participants
|
20 units per liter
STANDARD_DEVIATION 10 • n=7 Participants
|
22 units per liter
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Creatinine Level
|
0.9 milligrams per deciliter
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.9 milligrams per deciliter
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.9 milligrams per deciliter
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Hemoglobin Level
|
14 grams per deciliter
STANDARD_DEVIATION 2 • n=5 Participants
|
13 grams per deciliter
STANDARD_DEVIATION 2 • n=7 Participants
|
13 grams per deciliter
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Platelets Count
|
296 billion cells per liter
STANDARD_DEVIATION 90 • n=5 Participants
|
285 billion cells per liter
STANDARD_DEVIATION 51 • n=7 Participants
|
293 billion cells per liter
STANDARD_DEVIATION 82 • n=5 Participants
|
|
thyroid-stimulating hormone (TSH) level
|
1.8 milli-international units per liter
STANDARD_DEVIATION 1.4 • n=5 Participants
|
1.8 milli-international units per liter
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.8 milli-international units per liter
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Vitamin B12 Level
|
497 picograms per milliliter
STANDARD_DEVIATION 178 • n=5 Participants
|
495 picograms per milliliter
STANDARD_DEVIATION 255 • n=7 Participants
|
496 picograms per milliliter
STANDARD_DEVIATION 199 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after start of each interventionnatural log transformed data is reported
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
|
7.88 natural log(arbitrary units)
Interval 7.16 to 8.6
|
7.67 natural log(arbitrary units)
Interval 6.98 to 8.35
|
PRIMARY outcome
Timeframe: 6 weeks after start of each interventionUncoupling protein 1 (UCP1) is a marker of beige/brown fat. natural log transformed data is reported
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Uncoupling Protein 1 (UCP1) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
|
1.69 natural log(arbitrary units)
Interval -1.26 to 4.63
|
3.78 natural log(arbitrary units)
Interval 1.68 to 5.87
|
PRIMARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
signaling intermediary with interleukin-6
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPR domain containing 16 (PRDM16) is a marker of beige/brown fat. natural log transformed data is reported.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
PR Domain Containing 16 (PRDM16) Messenger Ribonucleic Acid (mRNA) Level ((From Adipose Tissue)
|
2.58 natural log(arbitrary units)
Interval 1.47 to 3.69
|
2.53 natural log(arbitrary units)
Interval 1.48 to 3.58
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
marker of beige/brown fat
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
marker of beige/brown fat
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
marker of beige/brown fat
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
marker of beige/brown fat
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
signaling intermediary with interleukin-6
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
signaling intermediary with interleukin-6
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionnatural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Cytokine IL-6 Level (From Plasma)
|
-0.20 natural log(picograms per milliliter)
Interval -0.93 to 0.53
|
-0.46 natural log(picograms per milliliter)
Interval -1.15 to 0.22
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionFree fatty acids level is a marker for insulin resistance. natural log transformed data is reported The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Free Fatty Acids Level (From Plasma)
|
-5.15 natural log(nanomoles per liter)
Interval -5.76 to -4.55
|
-5.68 natural log(nanomoles per liter)
Interval -6.22 to -5.14
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionInsulin Level is a marker of insulin resistance. natural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Insulin Level (From Plasma)
|
4.10 natural log(picomoles per liter)
Interval 3.77 to 4.43
|
3.86 natural log(picomoles per liter)
Interval 3.55 to 4.16
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionGlucose Level is a marker of insulin resistance. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Glucose Level (From Plasma)
|
80.61 milligrams per deciliter
Interval 76.08 to 85.14
|
78.50 milligrams per deciliter
Interval 74.22 to 82.78
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionnatural log transformed data is reported. The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (From Plasma)
|
.11 natural log(picograms per milliliter)
Interval -1.22 to 1.45
|
0.33 natural log(picograms per milliliter)
Interval -0.28 to 0.95
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
cytokine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionThe "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Glucagon-like Peptide-1 (From Plasma)
|
40.66 picomoles per milliliter
Interval 20.82 to 60.49
|
206.15 picomoles per milliliter
Interval 187.42 to 224.88
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionHomeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a marker of insulin resistance, calculated according to the formula: fasting insulin (mU/mL) x fasting glucose (mmol/L)/22.5 The "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
2.36 HOMA-IR score
Interval 1.77 to 2.95
|
1.63 HOMA-IR score
Interval 1.08 to 2.17
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionThe "Measure Type" indicated as "Mean" actually refers to a "Adjusted Mean." Mean was adjusted for meteorological season. The meteorological season (i.e., spring, summer, fall, and winter) was adjusted for in the multivariable analysis as a potential confounding factor, since imbalances in ambient temperature between study arms could affect the findings.
Outcome measures
| Measure |
Cyanocobalamin
n=18 Participants
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=18 Participants
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading)
Right side PET- CT
|
0.88 standard uptake value
Interval 0.23 to 1.52
|
1.37 standard uptake value
Interval 0.48 to 2.27
|
|
Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading)
Left side PET-CT
|
0.81 standard uptake value
Interval 0.23 to 1.39
|
1.26 standard uptake value
Interval 0.45 to 2.08
|
SECONDARY outcome
Timeframe: 6 weeks after start of each interventionPopulation: Data were not collected for this outcome measure.
measure of oxygen consumption
Outcome measures
Outcome data not reported
Adverse Events
Cyanocobalamin
Dulaglutide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyanocobalamin
n=23 participants at risk
Cyanocobalamin: Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
|
Dulaglutide
n=23 participants at risk
Dulaglutide: Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
|
|---|---|---|
|
General disorders
vasovagal response
|
4.3%
1/23 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
Additional Information
Absalon D Gutierrez, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place