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Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke (MAAS): study protocol for a randomized controlled trial.

Osei E, Fonville S, Zandbergen AA, Brouwers PJ, Mulder LJ, Lingsma HF, Dippel DW, Koudstaal PJ, den Hertog HM - Trials (2015)

Bottom Line: We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients.Patients allocated to sitagliptin will be treated with a daily fixed dose of 100 mg.NTR3196 , Date of registration: 15 December 2011.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, Medisch Spectrum Twente, PO Box 50 000, Enschede, 7500, KA, The Netherlands. e.osei@mst.nl.

ABSTRACT

Background: Impaired glucose tolerance is present in one third of patients with a TIA or ischemic stroke and is associated with a two-fold risk of recurrent stroke. Metformin improves glucose tolerance, but often leads to side effects. The aim of this study is to explore the feasibility, safety, and effects on glucose metabolism of metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients.

Methods/design: The Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke trial (MAAS trial) is a phase II, multicenter, randomized, controlled, open-label trial with blinded outcome assessment. Non-diabetic patients (n = 100) with a recent (<6 months) TIA, amaurosis fugax or minor ischemic stroke (modified Rankin scale ≤ 3) and impaired glucose tolerance, defined as 2-hour post-load glucose levels between 7.8 and 11.0 mmol/L after repeated standard oral glucose tolerance test, will be included. Patients with renal or liver impairment, heart failure, chronic hypoxic lung disease stage III-IV, history of lactate acidosis or diabetic ketoacidosis, pregnancy or breastfeeding, pancreatitis and use of digoxin will be excluded. The patients will be randomly assigned in a 1:1:2 ratio to metformin, sitagliptin or "no treatment." Patients allocated to metformin will start with 500 mg twice daily, which will be slowly increased during a 6-week period to a twice daily dose of 1000 mg. Patients allocated to sitagliptin will be treated with a daily fixed dose of 100 mg. The study has been registered as NTR 3196 in The Netherlands Trial Register. Primary outcomes include percentage still on treatment, percentage of (serious) adverse events, and the baseline adjusted difference in 2-hour post-load glucose levels at 6 months.

Discussion: This study will give more information about the feasibility and safety of metformin and sitagliptin as well as the effect on 2-hour post-load glucose levels at 6 months in patients with TIA or ischemic stroke and impaired glucose tolerance.

Trial registration number: NTR3196 , Date of registration: 15 December 2011.

No MeSH data available.


Related in: MedlinePlus

Flowchart study design
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Fig1: Flowchart study design

Mentions: At the follow-up visit, patients will be asked to complete a single questionnaire to determine compliance and nature of any of the side effects of the study medication. Patients will also be contacted by telephone for recording of possible adverse events and to support continuation of treatment at 2 weeks, 6 weeks, and 3 months after inclusion. If necessary (e.g. in case of unmanageable side effects), the number of telephone contacts and or follow-up visits will be intensified. Before randomization and at 6 months, all patients will undergo an OGTT with 75 g of glucose. Fasting glucose levels, body mass index (BMI), waist circumference, blood pressure and lipid profile will be assessed at baseline, and at 6 months (Fig. 1).


Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke (MAAS): study protocol for a randomized controlled trial.

Osei E, Fonville S, Zandbergen AA, Brouwers PJ, Mulder LJ, Lingsma HF, Dippel DW, Koudstaal PJ, den Hertog HM - Trials (2015)

Flowchart study design
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4526305&req=5

Fig1: Flowchart study design
Mentions: At the follow-up visit, patients will be asked to complete a single questionnaire to determine compliance and nature of any of the side effects of the study medication. Patients will also be contacted by telephone for recording of possible adverse events and to support continuation of treatment at 2 weeks, 6 weeks, and 3 months after inclusion. If necessary (e.g. in case of unmanageable side effects), the number of telephone contacts and or follow-up visits will be intensified. Before randomization and at 6 months, all patients will undergo an OGTT with 75 g of glucose. Fasting glucose levels, body mass index (BMI), waist circumference, blood pressure and lipid profile will be assessed at baseline, and at 6 months (Fig. 1).

Bottom Line: We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients.Patients allocated to sitagliptin will be treated with a daily fixed dose of 100 mg.NTR3196 , Date of registration: 15 December 2011.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, Medisch Spectrum Twente, PO Box 50 000, Enschede, 7500, KA, The Netherlands. e.osei@mst.nl.

ABSTRACT

Background: Impaired glucose tolerance is present in one third of patients with a TIA or ischemic stroke and is associated with a two-fold risk of recurrent stroke. Metformin improves glucose tolerance, but often leads to side effects. The aim of this study is to explore the feasibility, safety, and effects on glucose metabolism of metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients.

Methods/design: The Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke trial (MAAS trial) is a phase II, multicenter, randomized, controlled, open-label trial with blinded outcome assessment. Non-diabetic patients (n = 100) with a recent (<6 months) TIA, amaurosis fugax or minor ischemic stroke (modified Rankin scale ≤ 3) and impaired glucose tolerance, defined as 2-hour post-load glucose levels between 7.8 and 11.0 mmol/L after repeated standard oral glucose tolerance test, will be included. Patients with renal or liver impairment, heart failure, chronic hypoxic lung disease stage III-IV, history of lactate acidosis or diabetic ketoacidosis, pregnancy or breastfeeding, pancreatitis and use of digoxin will be excluded. The patients will be randomly assigned in a 1:1:2 ratio to metformin, sitagliptin or "no treatment." Patients allocated to metformin will start with 500 mg twice daily, which will be slowly increased during a 6-week period to a twice daily dose of 1000 mg. Patients allocated to sitagliptin will be treated with a daily fixed dose of 100 mg. The study has been registered as NTR 3196 in The Netherlands Trial Register. Primary outcomes include percentage still on treatment, percentage of (serious) adverse events, and the baseline adjusted difference in 2-hour post-load glucose levels at 6 months.

Discussion: This study will give more information about the feasibility and safety of metformin and sitagliptin as well as the effect on 2-hour post-load glucose levels at 6 months in patients with TIA or ischemic stroke and impaired glucose tolerance.

Trial registration number: NTR3196 , Date of registration: 15 December 2011.

No MeSH data available.


Related in: MedlinePlus