Insulin Resistance Clinical Trial
Official title:
Effect of Linagliptin + Metformin on Glucose Metabolism and Pancreatic Beta Cell Function in Patients With Prediabetes Who do Not Achieve Normoglycemia After 12 Months of Treatment With Metformin Alone
The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.
Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive
linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin
850mg every 12 h + lifestyle modification program during 6 months. Randomization will be
performed using an electronic random numbers table by a Nutritionist not involved in the
study. Participants and investigators involved in the patients follow-up and outcome
measurements will be masked to treatment allocation during the entire study.
Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes;
medications tolerance and side effects will be recorded in every patients´ visit. Nutritional
and physical activity assessment according to the patient´s weight will be performed by a
Nutritionist every month. Monthly adherence to medications will be evaluated by pill
counting; nutritional adherence and energy intake will be evaluated at 6 months by a food
frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months
patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile
during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression
to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive
measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl,
or 2 h glucose ≥ 200 mg/dl.
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