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Study on the effect of alpha glucosidase inhibitors on glycemic variability in patients of type 1 diabetes mellitus

A randomized placebo controlled study on effect of Alpha glucosidase inhibitors on glycemic variability in patients of Type 1 Diabetes mellitus - PROVIDE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049038
Enrollment
50
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications

Interventions

Intervention1: Acarbose: Acarbose tablets will be provided to the patients. Dose : 25 mg tds for 2 weeks, up titrated to 50 mg tds for 10 weeks Duration: 12 weeks Route: Oral Control Intervention1: P

Sponsors

Institutional
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 1 Diabetes mellitus patients (atleast 6 months duration) Age : 12-45 years HbA1c: = 7.5% and =12%

Exclusion criteria

Exclusion criteria: Pregnant or lactating females Known Hypersensitivity to AGIs Diabetic ketoacidosis Recent acute illness Renal dysfunction (S. Creatinine =2mg/dl and/or eGFR Chronic liver disease Inflammatory bowel disease/ intestinal obstruction/ Chronic intestinal malabsorptive disorders Hemoglobinopathies

Design outcomes

Primary

MeasureTime frame
To compare the effect of alpha glucosidase inhibitor with placebo on glycemic control and glycemic variability parameters using CGMS in patients of Type 1 diabetes mellitus on insulin at the end of 12 weeks and/or 24 weeksTimepoint: 12 weeks and/or 24 weeks—

Secondary

MeasureTime frame
To compare HbA1c between the two groups at 12 weeks and/or 24 weeksTimepoint: 12 weeks and/or 24 weeks;To compare markers of oxidative stress (urinary 8-Iso PGF-2a) and inflammation (IL-6) between the two groups at 12 weeks and/or 24 weeksTimepoint: 12 weeks and/or 24 weeks;To study the adverse effects of alpha glucosidase inhibitors in Type 1 diabetics Timepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr Azher Rizvi

All India Institute of Medical Sciences, Jodhpur

rizvi.azher@gmail.com9305061965

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026