Status:
NOT_YET_RECRUITING
Lactate and Glycerol Contribution to Gluconeogenesis
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 incl...
Detailed Description
Objectives: 1. Compare glycerol and lactate as carbon sources for GNG in humans with and without T2D. 2. Compare the contribution of glycerol and lactate to GNG during a hyperglucagonemic state. Hyp...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Subjects
- 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
- No evidence of T2D or prediabetes as per ADA criteria.
- 30.0 ≤ BMI ≤ 45.0 kg/m2.
- Inclusion Criteria for T2D Subjects
- Evidence of T2D as indicated by ADA criteria.
- 6.5% ≤ HbA1c ≤ 8.0%.
- 30.0 ≤ BMI ≤ 45.0 kg/m2.
- Exclusion Criteria for All Subjects
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06955130
Start Date
July 1 2026
End Date
April 30 2030
Last Update
December 2 2025
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