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NCT06955130Not yet recruiting

Lactate and Glycerol Contribution to Gluconeogenesis

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
24 Apr 2025
Start date
1 Jul 2026
Primary completion date
30 Apr 2029
Lead sponsor
Rutgers, The State University of New Jersey
NCT number
NCT06955130

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From 1 Jul 2026 to the primary completion date, 30 Apr 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy.

Other illness

  • Type 1 diabetes mellitus diagnosis and/or history of diabetic ketoacidosis.

Lab values

  • 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.

Who the study is looking for

  • Age 40-70 years.
  • The subject is otherwise in general good health, based on medical history and physical examination.
  • 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.
  • 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.

Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.