Glucose IntolerancePhase 4NCT04387201
GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
A Phase 4 study testing Cyanocobalamin and Dulaglutide in people with Glucose Intolerance and Overweight and Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This project investigates the anti-obesity mechanisms of glucagon-like peptide-1 (GLP-1) analogs, which are used in the treatment of human obesity and diabetes mellitus. The investigators will test if GLP-1 induces secretion of interleukin-6 (IL-6), a cytokine that may collaborate with GLP-1 analogs to induce the… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Glucose Intolerance, Overweight and Obesity, Drug Effect
- What is being tested?
- Cyanocobalamin and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 6 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women, ages 18-50 years
- Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.5% to 6.4%.
- BMI ≤ 35 kg/m2
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, oral contraception, vaginal rings, long-acting reversible contraceptives, or surgical sterilization) for the duration of the study
- Patients must have the following laboratory values: Hematocrit ≥ 33 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase < 2.5 times ULN
- If patients are receiving antihypertensive medications (other than beta blockers) and/or lipid-lowering medications, they must remain on stable doses for the duration of the study.
- If patients are receiving NSAIDs or antioxidant vitamins, these must be discontinued one week prior to study initiation and cannot be restarted during the study.
- If patient takes thyroid medications, these must be dosed to control hypo- or hyperthyroidism.
Who cannot join
- History of Type 1 or Type 2 diabetes mellitus
- Pregnant or breastfeeding women
- Medications: Beta blockers, corticosteroids, monoamine oxidase inhibitors, diabetes medications (including incretin mimetics and thiazolidinediones), and/or immunosuppressive therapy over the last 2 months.
- Uncontrolled hypo- or hyperthyroidism
- Current tobacco use
- Active malignancy
Show all 13Show fewer
- History of clinically significant cardiac, hepatic, or renal disease.
- History of any serious hypersensitivity reaction to study medications, any other incretin mimetic, any other formulation of supplemental vitamin B12, and/or cobalt
- Personal or family history of Leber hereditary optic nerve atrophy
- Prisoners or subjects who are involuntarily incarcerated
- Compulsorily detention for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- Prior history of pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN 2)
- Serum vitamin B12 level above the upper limit of assay detection
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
This project investigates the anti-obesity mechanisms of glucagon-like peptide-1 (GLP-1) analogs, which are used in the treatment of human obesity and diabetes mellitus. The investigators will test if GLP-1 induces secretion of interleukin-6 (IL-6), a cytokine that may collaborate with GLP-1 analogs to induce the formation of brown fat, which has anti-diabetic properties. The results will guide future obesity and diabetes mellitus therapies.
Read the detailed description
Incretins, the analogs of glucagon-like peptide-1 (GLP-1), improve glucose control in type 2 diabetes mellitus and counteract obesity through mechanisms that are not completely understood. The investigators' preliminary data show that, in prediabetic human subjects and mice, GLP-1 analog therapy induces an increase in plasma interleukin-6 (IL-6), a cytokine activating signal transducer and activator of transcription 3 (STAT3) signaling, which induces brown (beige) adipocyte differentiation in adipose tissue (AT). The investigators discovered that plasma IL-6 induction occurs through GLP-1 receptor (GLP-1R) stimulation in leukocytes. Interestingly, studies in rodents indicate that GLP-1 / GLP-1R signaling also induces AT beiging. Based on these observations, the investigators hypothesize that incretins induce AT browning in part via transient IL-6 / IL-6 receptor (IL-6R) / STAT3 signaling. The primary objective is to further elucidate the role of IL-6 and GLP-1 signaling in mediating beneficial metabolic effects of incretin therapy. Studies will be paralleled in a human clinical trial, a human cell culture model, and a mouse diet-induced obesity model. GLP-1 analog therapy combined with an IL-6 blocking antibody will be used. Specific Aim 1 is to (A) investigate IL-6 induction / downstream STAT3 signaling and AT browning upon incretin therapy in prediabetic human subjects; and (B) validate mice as a model to study incretin-induced IL-6 signaling as a mediator of AT browning. Specific Aim 2 is to (A) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in human adipocyte progenitors; and (B) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in mice. It is expected that 1) GLP-1 analog signaling via GLP-1R induces IL-6 secretion by leukocytes, and 2) GLP-1 analog therapy induces adipose tissue browning via both direct GLP-1 / GLP-1R signaling and indirect incretin-induced IL-6 / IL-6R / STAT3 signaling. The results of this novel study will give critical insights on the anti-obesity mechanisms of GLP-1 analogs and serve as the basis for developing more targeted therapies for diabetes and obesity. Understanding the anti-diabetic IL-6 effects will also be important for interpreting the results of IL-6 blockade, a therapeutic approach for patients with diabetes and other inflammatory conditions, which may need to be re-considered.
- Conditions
- Glucose Intolerance, Overweight and Obesity, Drug Effect, Adiposity
- Being tested
- Cyanocobalamin, Dulaglutide
- Keywords
- GLP-1, prediabetes, brown fat, adipose tissue, IL-6
- Medical subject headings
- Glucose Intolerance, Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyanocobalaminDrug
Also called Vitamin B12
Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
DulaglutideDrug
Also called Trulicity
Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cyanocobalamin, then Dulaglutide | Experimental | 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 Receives: Drug: Cyanocobalamin; Drug: Dulaglutide |
| Dulaglutide, then Cyanocobalamin | Experimental | 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. Receives: Drug: Cyanocobalamin; Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
natural log transformed data is reported
Measured: 6 weeks after start of each intervention
Uncoupling Protein 1 (UCP1) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
Uncoupling protein 1 (UCP1) is a marker of beige/brown fat. natural log transformed data is reported
Measured: 6 weeks after start of each intervention
Signal Transducer and Activator of Transcription 3 (STAT3) Band Intensity/Western Blot (From Adipose Tissue)
signaling intermediary with interleukin-6
Measured: 6 weeks after start of each intervention
Secondary outcomes (22)
PR Domain Containing 16 (PRDM16) Messenger Ribonucleic Acid (mRNA) Level ((From Adipose Tissue)
PR domain containing 16 (PRDM16) is a marker of beige/brown fat. natural log transformed data is reported.
Measured: 6 weeks after start of each intervention
Nicotinamide Adenine Dinucleotide Dehydrogenase (Ubiquinone) Iron-sulfur protein3 (NDUFS3) (From Adipose Tissue)
marker of beige/brown fat
Measured: 6 weeks after start of each intervention
Beta1-adrenoceptor (ADRB1) (From Adipose Tissue)
marker of beige/brown fat
Measured: 6 weeks after start of each intervention
Beta2-adrenoceptor (ADRB2) (From Adipose Tissue)
marker of beige/brown fat
Measured: 6 weeks after start of each intervention
Beta3-adrenoceptor (ADRB3) (From Adipose Tissue)
marker of beige/brown fat
Measured: 6 weeks after start of each intervention
Nuclear Factor Kappa B (NfKappaB) p65 Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells)
signaling intermediary with interleukin-6
Measured: 6 weeks after start of each intervention
Interleukin-6 (IL-6) mRNA (From Peripheral Blood Mononuclear Cells)
cytokine
Measured: 6 weeks after start of each intervention
IL-6 (From Peripheral Blood Mononuclear Cells)
cytokine
Measured: 6 weeks after start of each intervention
Suppressor of Cytokine Signaling 3 (SOCS3) Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells)
signaling intermediary with interleukin-6
Measured: 6 weeks after start of each intervention
Cytokine IL-6 Level (From Plasma)
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.
Measured: 6 weeks after start of each intervention
Free Fatty Acids Level (From Plasma)
Free 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.
Measured: 6 weeks after start of each intervention
Insulin Level (From Plasma)
Insulin 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.
Measured: 6 weeks after start of each intervention
Glucose Level (From Plasma)
Glucose 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.
Measured: 6 weeks after start of each intervention
Tumor Necrosis Factor - Alpha (From Plasma)
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.
Measured: 6 weeks after start of each intervention
Interleukin-4 (From Plasma)
cytokine
Measured: 6 weeks after start of each intervention
Interleukin-10 (From Plasma)
cytokine
Measured: 6 weeks after start of each intervention
Interleukin-11 (From Plasma)
cytokine
Measured: 6 weeks after start of each intervention
Interleukin-13 (From Plasma)
cytokine
Measured: 6 weeks after start of each intervention
Glucagon-like Peptide-1 (From Plasma)
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.
Measured: 6 weeks after start of each intervention
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Homeostatic 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.
Measured: 6 weeks after start of each intervention
Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading)
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.
Measured: 6 weeks after start of each intervention
Oroboros Oxygen Consumption
measure of oxygen consumption
Measured: 6 weeks after start of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 May 2020
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Absalon D Gutierrez, The University of Texas Health Science Center, Houston
- Investigators
- Absalon D Gutierrez, MD, Principal investigator, The University of Texas Health Science Center at Houston, Dept. of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387201
- Sponsor's protocol ID
- HSC-MS-19-0787
- Other IDs
- R21DK122234
- Status last verified
- Nov 2024
- First submitted
- 6 May 2020
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all participant data (which will be deidentified) regarding our plasma samples, subcutaneous adipose tissue samples, and peripheral blood mononuclear cells. A study protocol and statistical analysis plan will be available as specified per policy of clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
- ClinicalTrials.gov ID
- NCT04387201
- Acronym / sponsor ID
- HSC-MS-19-0787
- Conditions
- Glucose Intolerance, Overweight and Obesity, Drug Effect, Adiposity
- Keywords
- GLP-1, prediabetes, brown fat, adipose tissue, IL-6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project investigates the anti-obesity mechanisms of glucagon-like peptide-1 (GLP-1) analogs, which are used in the treatment of human obesity and diabetes mellitus. The investigators will test if GLP-1 induces secretion of interleukin-6 (IL-6), a cytokine that may collaborate with GLP-1 analogs to induce the formation of brown fat, which has anti-diabetic properties. The results will guide future obesity and diabetes mellitus therapies.
Detailed description
Incretins, the analogs of glucagon-like peptide-1 (GLP-1), improve glucose control in type 2 diabetes mellitus and counteract obesity through mechanisms that are not completely understood. The investigators' preliminary data show that, in prediabetic human subjects and mice, GLP-1 analog therapy induces an increase in plasma interleukin-6 (IL-6), a cytokine activating signal transducer and activator of transcription 3 (STAT3) signaling, which induces brown (beige) adipocyte differentiation in adipose tissue (AT). The investigators discovered that plasma IL-6 induction occurs through GLP-1 receptor (GLP-1R) stimulation in leukocytes. Interestingly, studies in rodents indicate that GLP-1 / GLP-1R signaling also induces AT beiging. Based on these observations, the investigators hypothesize that incretins induce AT browning in part via transient IL-6 / IL-6 receptor (IL-6R) / STAT3 signaling. The primary objective is to further elucidate the role of IL-6 and GLP-1 signaling in mediating beneficial metabolic effects of incretin therapy. Studies will be paralleled in a human clinical trial, a human cell culture model, and a mouse diet-induced obesity model. GLP-1 analog therapy combined with an IL-6 blocking antibody will be used. Specific Aim 1 is to (A) investigate IL-6 induction / downstream STAT3 signaling and AT browning upon incretin therapy in prediabetic human subjects; and (B) validate mice as a model to study incretin-induced IL-6 signaling as a mediator of AT browning. Specific Aim 2 is to (A) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in human adipocyte progenitors; and (B) investigate if GLP-1 analog effects on beige adipogenesis depend on IL-6 signaling in mice. It is expected that 1) GLP-1 analog signaling via GLP-1R induces IL-6 secretion by leukocytes, and 2) GLP-1 analog therapy induces adipose tissue browning via both direct GLP-1 / GLP-1R signaling and indirect incretin-induced IL-6 / IL-6R / STAT3 signaling. The results of this novel study will give critical insights on the anti-obesity mechanisms of GLP-1 analogs and serve as the basis for developing more targeted therapies for diabetes and obesity. Understanding the anti-diabetic IL-6 effects will also be important for interpreting the results of IL-6 blockade, a therapeutic approach for patients with diabetes and other inflammatory conditions, which may need to be re-considered.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cyanocobalamin, then Dulaglutide | Experimental | Drug: Cyanocobalamin, Drug: DulaglutideParticipants 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 |
| Dulaglutide, then Cyanocobalamin | Experimental | Drug: Cyanocobalamin, Drug: DulaglutideParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women, ages 18-50 years
- Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.5% to 6.4%.
- BMI ≤ 35 kg/m2
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, oral contraception, vaginal rings, long-acting reversible contraceptives, or surgical sterilization) for the duration of the study
- Patients must have the following laboratory values: Hematocrit ≥ 33 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase < 2.5 times ULN
Key exclusion criteria (13 listed)
- History of Type 1 or Type 2 diabetes mellitus
- Pregnant or breastfeeding women
- Medications: Beta blockers, corticosteroids, monoamine oxidase inhibitors, diabetes medications (including incretin mimetics and thiazolidinediones), and/or immunosuppressive therapy over the last 2 months.
- Uncontrolled hypo- or hyperthyroidism
- Current tobacco use
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 |
|---|---|---|
| CyanocobalaminAlso: Vitamin B12Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. | Drug | Cyanocobalamin, then Dulaglutide, Dulaglutide, then Cyanocobalamin |
| DulaglutideAlso: TrulicityDulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks | Drug | Cyanocobalamin, then Dulaglutide, Dulaglutide, then Cyanocobalamin |
Primary outcome
Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
natural log transformed data is reported
Uncoupling Protein 1 (UCP1) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Uncoupling protein 1 (UCP1) is a marker of beige/brown fat. natural log transformed data is reported
Signal Transducer and Activator of Transcription 3 (STAT3) Band Intensity/Western Blot (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
signaling intermediary with interleukin-6
22 secondary outcomes
PR Domain Containing 16 (PRDM16) Messenger Ribonucleic Acid (mRNA) Level ((From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Nicotinamide Adenine Dinucleotide Dehydrogenase (Ubiquinone) Iron-sulfur protein3 (NDUFS3) (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Beta1-adrenoceptor (ADRB1) (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Beta2-adrenoceptor (ADRB2) (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Beta3-adrenoceptor (ADRB3) (From Adipose Tissue)
Time frame: 6 weeks after start of each intervention
Nuclear Factor Kappa B (NfKappaB) p65 Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells)
Time frame: 6 weeks after start of each intervention
Interleukin-6 (IL-6) mRNA (From Peripheral Blood Mononuclear Cells)
Time frame: 6 weeks after start of each intervention
IL-6 (From Peripheral Blood Mononuclear Cells)
Time frame: 6 weeks after start of each intervention
Suppressor of Cytokine Signaling 3 (SOCS3) Band Intensity/Western Blot (From Peripheral Blood Mononuclear Cells)
Time frame: 6 weeks after start of each intervention
Cytokine IL-6 Level (From Plasma)
Time frame: 6 weeks after start of each intervention
Free Fatty Acids Level (From Plasma)
Time frame: 6 weeks after start of each intervention
Insulin Level (From Plasma)
Time frame: 6 weeks after start of each intervention
Glucose Level (From Plasma)
Time frame: 6 weeks after start of each intervention
Tumor Necrosis Factor - Alpha (From Plasma)
Time frame: 6 weeks after start of each intervention
Interleukin-4 (From Plasma)
Time frame: 6 weeks after start of each intervention
Interleukin-10 (From Plasma)
Time frame: 6 weeks after start of each intervention
Interleukin-11 (From Plasma)
Time frame: 6 weeks after start of each intervention
Interleukin-13 (From Plasma)
Time frame: 6 weeks after start of each intervention
Glucagon-like Peptide-1 (From Plasma)
Time frame: 6 weeks after start of each intervention
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 6 weeks after start of each intervention
Fat Browning Measured as Standard Uptake Value (From Positron Emission Tomography - Computed Tomography (PET-CT) Reading)
Time frame: 6 weeks after start of each intervention
Oroboros Oxygen Consumption
Time frame: 6 weeks after start of each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will share all participant data (which will be deidentified) regarding our plasma samples, subcutaneous adipose tissue samples, and peripheral blood mononuclear cells. A study protocol and statistical analysis plan will be available as specified per policy of clinicaltrials.gov.
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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.
Absalon D Gutierrez, MD principal investigator
The University of Texas Health Science Center at Houston, Dept. of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyanocobalamin and Dulaglutide in people with Glucose Intolerance and Overweight and Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 5 Dec 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) (time frame: 6 weeks after start of each intervention). The study lists 3 primary outcomes in all. 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 5 Dec 2024.