Type 2 DiabetesNCT06955130
Lactate and Glycerol Contribution to Gluconeogenesis
A study testing Glycerol, Lactate and Glucose in people with Type 2 Diabetes and Obesity, run by Rutgers, The State University of New Jersey.
Trial summary
A major cause of increased blood glucose levels in type 2 diabetes (T2D) is increased hepatic gluconeogenesis (GNG), as the liver converts various substrates into glucose. Two of these substrates include glycerol, a molecule from fat, and lactate, a molecule that circulates in the blood. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Healthy
- What is being tested?
- Glycerol, Lactate and Glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-70 years.
- The subject is otherwise in general good health, based on medical history and physical examination.
- Inclusion Criteria for Metabolically Healthy Subjects without Obesity
- No evidence of T2D or prediabetes as indicated by the American Diabetes Association (ADA), i.e., HbA1c < 5.7%, fasting glucose < 100 mg/dL, or use of glucose-lowering medications.
- Body mass index (BMI) ≤ 24.9 kg/m2.
- Inclusion Criteria for Metabolically Healthy Subjects with Obesity
Show all 11Show fewer
- No evidence of T2D or prediabetes as per ADA criteria.
- 30.0 ≤ BMI ≤ 45.0 kg/m2.
- Evidence of T2D as indicated by ADA criteria.
- 6.5% ≤ HbA1c ≤ 8.0%.
- 30.0 ≤ BMI ≤ 45.0 kg/m2.
Who cannot join
- Chronic medical conditions that may affect glucose metabolism, including active malignancy, tobacco use, HIV infection, kidney failure, liver dysfunction, alcoholism, pancreatitis, active viral/bacterial infection, current pregnancy/lactation, anemia, severe cardiac or respiratory failure, and uncontrolled hyperlipidemia (total cholesterol ≥ 260 mg/dL or triglycerides ≥400 mg/dL).
- Current medical therapy that affects glucose metabolism such as glucocorticoid, antipsychotic, or oral contraceptive pills.
- Type 1 diabetes mellitus diagnosis and/or history of diabetic ketoacidosis.
- Use of weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A major cause of increased blood glucose levels in type 2 diabetes (T2D) is increased hepatic gluconeogenesis (GNG), as the liver converts various substrates into glucose. Two of these substrates include glycerol, a molecule from fat, and lactate, a molecule that circulates in the blood. Our previously collected data suggest that glycerol's role in this process has been underestimated, so the investigators will directly compare the carbon contribution of glycerol and lactate to new glucose production under fasting conditions in patients with and without T2D. The investigators will also assess how glucagon, a hormone that raises blood glucose levels, impacts the conversion of glycerol and lactate to glucose. Enrolled participants will undergo three separate isotope tracer infusions with serial blood collections for liquid chromatography-mass spectrometry analysis. This research could identify new therapeutic drug targets that can lower blood glucose levels more directly and effectively.
Read the detailed description
Objectives:
- Compare glycerol and lactate as carbon sources for GNG in humans with and without T2D.
- Compare the contribution of glycerol and lactate to GNG during a hyperglucagonemic state.
Hypothesis:
- Glycerol contributes to glucose and lactate production, while lactate is not a net carbon contributor to glucose or glycerol production.
- Glycerol, not lactate, potentiates the observed increases in GNG seen in T2D.
- Glucagon promotes greater glycerol incorporation into glucose as compared to lactate incorporation into glucose.
Study Design:
The investigators will recruit three different adult metabolic cohorts (16 per cohort): 1) Lean, defined as body mass index (BMI) <25.0 kg/m2, and no T2D; 2) Obese (BMI ≥ 30.0 kg/m2) and no T2D; and 3) Obese (BMI ≥ 30.0 kg/m2) and with T2D. All subjects will be between the ages of 18 and 65. All subjects will perform a self-monitored overnight fast at home and then come for three separate isotope tracer infusions (13C3-glycerol, 13C3-lactate, and 13C6-glucose) with serial blood draws. Each tracer infusion will last eight hours. During the final two hours of the infusion, subjects will receive intravenous glucagon, which increases the amount of glucose the liver produces. Collected blood samples will undergo liquid chromatography-mass spectrometry (LC-MS) analysis in our laboratory. Additionally, all subjects will receive a body composition analysis via dual-energy X-ray absorptiometry (DXA).
- Conditions
- Type 2 Diabetes, Obesity, Healthy
- Being tested
- Glycerol, Lactate, Glucose
- Keywords
- diabetes, glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycerolDrug
Subjects will receive an infusion of glycerol and glucagon.
LactateDrug
Subjects will receive an infusion of lactate and glucagon.
GlucoseDrug
Subjects will receive an infusion of glucose and glucagon.
| Study group | Role | What they receive |
|---|---|---|
| Glycerol | Experimental | Each subject will receive labeled 13C3-glycerol. Receives: Drug: Glycerol |
| Lactate | Experimental | Each subject will receive labeled 13C3-lactate. Receives: Drug: Lactate |
| Glucose | Experimental | Each subject will receive labeled 13C6-glucose. Receives: Drug: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Contribution to Glucose Production
Net carbon flux from glycerol and lactate to glucose will be measured using LC-MS of plasma glucose via 13C-enrichment after infusion of various metabolic tracers
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Jul 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankit Shah, MD, Rutgers, The State University of New Jersey
- Investigators
- Ankit Shah, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955130
- Sponsor's protocol ID
- Pro2019002628
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final data to be shared with study sponsor
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate and Glycerol Contribution to Gluconeogenesis
- ClinicalTrials.gov ID
- NCT06955130
- Acronym / sponsor ID
- Pro2019002628
- Conditions
- Type 2 Diabetes, Obesity, Healthy
- Keywords
- diabetes, glucose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A major cause of increased blood glucose levels in type 2 diabetes (T2D) is increased hepatic gluconeogenesis (GNG), as the liver converts various substrates into glucose. Two of these substrates include glycerol, a molecule from fat, and lactate, a molecule that circulates in the blood. Our previously collected data suggest that glycerol's role in this process has been underestimated, so the investigators will directly compare the carbon contribution of glycerol and lactate to new glucose production under fasting conditions in patients with and without T2D. The investigators will also assess how glucagon, a hormone that raises blood glucose levels, impacts the conversion of glycerol and lactate to glucose. Enrolled participants will undergo three separate isotope tracer infusions with serial blood collections for liquid chromatography-mass spectrometry analysis. This research could identify new therapeutic drug targets that can lower blood glucose levels more directly and effectively.
Detailed description
Objectives:
- Compare glycerol and lactate as carbon sources for GNG in humans with and without T2D.
- Compare the contribution of glycerol and lactate to GNG during a hyperglucagonemic state.
Hypothesis:
- Glycerol contributes to glucose and lactate production, while lactate is not a net carbon contributor to glucose or glycerol production.
- Glycerol, not lactate, potentiates the observed increases in GNG seen in T2D.
- Glucagon promotes greater glycerol incorporation into glucose as compared to lactate incorporation into glucose.
Study Design:
The investigators will recruit three different adult metabolic cohorts (16 per cohort): 1) Lean, defined as body mass index (BMI) <25.0 kg/m2, and no T2D; 2) Obese (BMI ≥ 30.0 kg/m2) and no T2D; and 3) Obese (BMI ≥ 30.0 kg/m2) and with T2D. All subjects will be between the ages of 18 and 65. All subjects will perform a self-monitored overnight fast at home and then come for three separate isotope tracer infusions (13C3-glycerol, 13C3-lactate, and 13C6-glucose) with serial blood draws. Each tracer infusion will last eight hours. During the final two hours of the infusion, subjects will receive intravenous glucagon, which increases the amount of glucose the liver produces. Collected blood samples will undergo liquid chromatography-mass spectrometry (LC-MS) analysis in our laboratory. Additionally, all subjects will receive a body composition analysis via dual-energy X-ray absorptiometry (DXA).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glycerol | Experimental | Drug: GlycerolEach subject will receive labeled 13C3-glycerol. |
| Lactate | Experimental | Drug: LactateEach subject will receive labeled 13C3-lactate. |
| Glucose | Experimental | Drug: GlucoseEach subject will receive labeled 13C6-glucose. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 40-70 years.
- The subject is otherwise in general good health, based on medical history and physical examination.
- Inclusion Criteria for Metabolically Healthy Subjects without Obesity
- No evidence of T2D or prediabetes as indicated by the American Diabetes Association (ADA), i.e., HbA1c < 5.7%, fasting glucose < 100 mg/dL, or use of glucose-lowering medications.
- Body mass index (BMI) ≤ 24.9 kg/m2.
Key exclusion criteria (4 listed)
- Chronic medical conditions that may affect glucose metabolism, including active malignancy, tobacco use, HIV infection, kidney failure, liver dysfunction, alcoholism, pancreatitis, active viral/bacterial infection, current pregnancy/lactation, anemia, severe cardiac or respiratory failure, and uncontrolled hyperlipidemia (total cholesterol ≥ 260 mg/dL or triglycerides ≥400 mg/dL).
- Current medical therapy that affects glucose metabolism such as glucocorticoid, antipsychotic, or oral contraceptive pills.
- Type 1 diabetes mellitus diagnosis and/or history of diabetic ketoacidosis.
- Use of weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy.
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 |
|---|---|---|
| GlycerolSubjects will receive an infusion of glycerol and glucagon. | Drug | Glycerol |
| LactateSubjects will receive an infusion of lactate and glucagon. | Drug | Lactate |
| GlucoseSubjects will receive an infusion of glucose and glucagon. | Drug | Glucose |
Primary outcome
Carbon Contribution to Glucose Production
Time frame: 8 hours
Net carbon flux from glycerol and lactate to glucose will be measured using LC-MS of plasma glucose via 13C-enrichment after infusion of various metabolic tracers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Final data to be shared with study sponsor
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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.
Ankit Shah, MD principal investigator
Rutgers Robert Wood Johnson Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Glycerol, Lactate and Glucose in people with Type 2 Diabetes and Obesity, run by Rutgers, The State University of New Jersey.
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 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankit Shah, MD (7322356337, ashah386@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon Contribution to Glucose Production (time frame: 8 hours). 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 2 Dec 2025.