Phase 4
N=20
Effects of Antidiabetic Medications on the Postprandial State in Prediabetes
Prediabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02104739 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Monocyte NfkB Levels as Detected by Western Blotting — 62.79; 72.03; 67.68; 84.19 NfkB p65 arbitrary units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exenatide (Drug); Saxagliptin (Drug); Exenatide extended-release (ER) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocyte NfkB Levels as Detected by Western Blotting |
67.39; 68.39; 71.37; 93.47 | 0.27 |
| PRIMARY Monocyte NfkB Levels as Detected by Western Blotting |
67.39; 68.39; 71.37; 93.47 | 0.27 |
| SECONDARY Triglycerides |
161; 179; 200 | <0.05 sig |
| SECONDARY Triglycerides |
161; 179; 200 | <0.05 sig |
| SECONDARY Triglycerides |
161; 179; 200 | <0.05 sig |
| SECONDARY Triglycerides |
161; 179; 200 | <0.05 sig |
| SECONDARY Free Fatty Acids |
0.29; 0.31; 0.33 | <0.05 sig |
| SECONDARY Free Fatty Acids |
0.29; 0.31; 0.33 | <0.05 sig |
| SECONDARY Free Fatty Acids |
0.29; 0.31; 0.33 | <0.05 sig |
| SECONDARY Free Fatty Acids |
0.29; 0.31; 0.33 | <0.05 sig |
| SECONDARY Peak Forearm Blood Flow |
14.25; 15.87; 13.45 | >0.05 |
| SECONDARY Peak Forearm Blood Flow |
14.25; 15.87; 13.45 | >0.05 |
| SECONDARY Peak Forearm Blood Flow |
14.25; 15.87; 13.45 | >0.05 |
Summary
This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.
Eligibility Criteria
Inclusion Criteria
- 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 5.7% to 6.4%
- Subjects are allowed, but not required, to be on statins, ACE-inhibitors, beta-blockers, angiotensin-receptor blockers, thiazide diuretics, and/or loop diuretics at doses that have been stable for at least the last 3 months
- BMI between 30-35 kg/m2 (±1 kg/m2)
- Body weight has been stable (±4-5 pounds) over the prior three months.
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, or surgical sterilization) for the duration of the study
- Patients must have the following laboratory values: Hematocrit ≥ 34 vol% S. creatinine < 1.5 mg/dl in men and 1.4 mg/dl in women AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase< 2.5 times ULN
Exclusion Criteria
- History of Type 1 or Type 2 diabetes mellitus
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Pregnant or breastfeeding women
- Patients must not be receiving lipid-lowering medications other than statins within the last 3 months
- Patient must not be receiving metformin, DPP-IV inhibitors, GLP-1 agonists, thiazolidinediones, insulin, sulfonylureas, acarbose, SGLT-2 inhibitors, corticosteroids, or immunosuppressive therapy within the last 3 months and cannot take them for the duration of the study. Patient must not be receiving NSAIDS or antioxidant vitamins within the last 1 week, and cannot take them for the duration of the study.
- Patients must not be on hormone replacement therapy.
- Patients with diabetic gastroparesis
- Patients with current tobacco use
- Patients with active malignancy
- Patients with history of urinary bladder cancer
- Patients with dietary restrictions precluding a high-fat meal
- Patients with a history of clinically significant heart disease (NYHA III or IV; more than non- specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied
- Subjects with a history of any serious hypersensitivity reaction to the study medications
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- Subjects with known allergic reactions to the study medications or test meal
- Subjects unwilling or unable to provide informed consent
- Subjects determined by the investigator(s) to not be appropriate candidates for the study
Data sourced from ClinicalTrials.gov (NCT02104739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.