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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | July 1, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with prediabetes, defined for the existence of one or both of the following conditions: 1) impaired fasting glucose (Fasting glucose between 100 and 125 mg/dL), 2) impaired glucose tolerance (Glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance test (OGTT) - Patients who accept to participate in the study and sign the informed consent letter. Exclusion Criteria: - Patients with diagnosed Type 2 Diabetes Mellitus previously or detected during the OGTT - Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin. - Serum creatinine > 1.6 mg/dL - Hypertriglyceridemia very high (>500 mg/dL) - Pregnant women - Altered arterial hypertension (Systolic > 180 mmHg or Diastolic >105 mmHg) - Excessive alcohol intake, acute or chronic - Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing's syndrome, Thyrotoxicosis. |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad de Guanajuato | León | Guanauato |
Lead Sponsor | Collaborator |
---|---|
Universidad de Guanajuato | Hospital Regional de Alta Especialidad del Bajío |
Mexico,
DeFronzo RA, Bonadonna RC, Ferrannini E. Pathogenesis of NIDDM. A balanced overview. Diabetes Care. 1992 Mar;15(3):318-68. — View Citation
Faerch K, Borch-Johnsen K, Holst JJ, Vaag A. Pathophysiology and aetiology of impaired fasting glycaemia and impaired glucose tolerance: does it matter for prevention and treatment of type 2 diabetes? Diabetologia. 2009 Sep;52(9):1714-23. doi: 10.1007/s00125-009-1443-3. Epub 2009 Jul 10. — View Citation
Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. — View Citation
Hsu SM, Raine L, Fanger H. Use of avidin-biotin-peroxidase complex (ABC) in immunoperoxidase techniques: a comparison between ABC and unlabeled antibody (PAP) procedures. J Histochem Cytochem. 1981 Apr;29(4):577-80. — View Citation
King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. — View Citation
Schulz LO, Bennett PH, Ravussin E, Kidd JR, Kidd KK, Esparza J, Valencia ME. Effects of traditional and western environments on prevalence of type 2 diabetes in Pima Indians in Mexico and the U.S. Diabetes Care. 2006 Aug;29(8):1866-71. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from basal fasting and 2 hours glucose levels during the oral glucose tolerance test at 12 months | Fasting and post-2 hours glucose values (mg/dl) during the oral glucose tolerance test | 12 months | |
Secondary | Change from basal pancreatic beta cell function at 12 months | Evaluated with the Disposition index (DI), obtained from measurements of glucose and insulin during the oral glucose tolerance test. A higher value in the DI meas a better pancreatic beta cell function. There are not minimum and maximum levels | 12 months | |
Secondary | Change from basal insulin sensitivity at 12 months | Insulin sensitivity evaluated with the Matsuda Index, obtained with the insulina and glucose measurements during the oral glucose tolerance test. Matsuda index is reported in arbitrary units, and a higher value means a better insulin sensitivity. There are not minimum and maximum levels | 12 months |
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