Insulin Resistance Clinical Trial
Official title:
Effect of Low Dose Combination of Linagliptin and Metformin to Improve Pancreatic Beta Cell Function, Insulin Resistance and Cardiovascular Function in Patients With Prediabetes and Overweight/Obesity: Randomizer Clinical Trial
Type 2 diabetes is a chronic disease that has reached global epidemic proportions due to the
growing number of patients in all countries; It has become the disease that causes more
chronic and acute complications to patients, unfortunately, when the diagnosis of type 2
diabetes is made patients are identified at very advanced stages of the disease.
For all the above, the best strategies will be those that are aimed at early stages of the
disease, and the investigators are convinced that the use the combination of drugs with
additive pathophysiological effect plus cardiovascular protection in early stages, will have
better results, lasting and with greater results impact on the natural history of the disease
that throws measures that may have an applicability in clinical practice, in order to
contribute to the control of this pathology. Therefore, the combination of medications with
different mechanisms of action, in low doses, could be a useful strategy not only to prevent
type 2 diabetes, but also to prevent macro and microvascular complications early. The goal of
this clinical trial is to evaluate the effect of low doses of linagliptin + metformin vs
metformin alone on physiopathological parameters, such as glucose metabolism, insulin
resistance, insulin secretion and pancreatic beta cell function in patients with impaired
fasting glucose plus impaired glucose tolerance, during 12 months.
The main goal of this clinical trial is to compare the effect of two different treatments
during 12 months:
1. Lifestyle modification program + metformin 1700mg every 24 hours.
2. Lifestyle modification program + linagliptin (2.5mg) and metformin (1700mg) every 24
hours.
on the following parameters, after 12 months of treatment:
1. Glucose metabolism, evaluated by the oral glucose tolerance
2. Insulin resistance, evaluated by the oral glucose tolerance in 100% of the patients
3. Insulin secretion, evaluated by the oral glucose tolerance in 100% of the patients
4. Pancreatic beta cell function, evaluated by the oral glucose tolerance in 100% of the
patients
5. Cardiovascular function, evaluated by ejection fraction measurement, diastolic and
systolic preloads measured by standard echocardiography.
All the patients will have a basal evaluation with an oral glucose tolerance test, lipid
profile, body composition. After the basal evaluation, if the patients result with
prediabetes (FASTING IMPAIRED GLUCOSE/IMPAIRED GLUCOSE TOLERANCE) and have at least 2 risk
factors, they will be invited to the intervention phase where they will be randomized to one
of the two treatment groups.
Patients will have a follow-up visit every month to review the adherence to the lifestyle
modification program and to the medication. After 6 months, patients will repeat the same
evaluation performed as the basal evaluation.
;
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 |