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Completed

NCT Number: NCT04707508

Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nantou Christian Hospital

Nantou City, Nantou County, 540001, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults over 21 years of age
  • clinically diagnosed type 2 diabetes mellitus
  • recipients of metformin monotherapy
  • compliance with prescriptions and dietary intervention

Exclusion criteria

  • recipients of any second-line antidiabetic drug in addition to metformin
  • recipients of any antihypertensive medication before study enrollment
  • hemoglobin disorders
  • chronic kidney disease
  • thyroid dysfunction

Treatment and study plan

Valsartan 80 mg and metformin

Drug

Valsartan 80 mg once daily in addition to metformin monotherapy

metformin

Drug

Metformin monotherapy

Primary outcomes

  1. Serum glycosylated hemoglobin A1c

    Time frame: 24 weeks

    Change in serum glycosylated hemoglobin A1c of the participants

Secondary outcomes

  1. Plasma lipid fractions

    Time frame: 24 weeks

    Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol

  2. Blood pressure

    Time frame: 24 weeks

    Change in systolic blood pressure and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Nantou Christian Hospital

Other

Registry information

Official study title

Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2021
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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