Insulin Resistance Clinical Trial
Official title:
A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days
The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the
treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a
synthetic analog of a naturally occurring hormone with a potentially new mechanism of action
that may improve the current therapeutic options available to a T2DM patient.
The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the
observed activity of HE3286 in reducing insulin resistance in both impaired glucose
intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the
physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further
understand the mechanism of action and to design future clinical trials.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
| Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
| Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
| Completed |
NCT03383822 -
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
| Completed |
NCT04203238 -
Potato Research for Enhancing Metabolic Outcomes
|
N/A | |
| Recruiting |
NCT03658564 -
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
|
N/A | |
| Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
| Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
| Completed |
NCT03627104 -
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
|
N/A | |
| Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A | |
| Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
| Completed |
NCT03809182 -
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
|
Phase 4 | |
| Completed |
NCT01809288 -
Identifying Risk for Diabetes and Heart Disease in Women
|
||
| Completed |
NCT04642482 -
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
|
Phase 4 | |
| Terminated |
NCT03278236 -
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
|
N/A | |
| Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
| Withdrawn |
NCT04741204 -
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
|
Phase 4 | |
| Not yet recruiting |
NCT05540249 -
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
|
N/A |