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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Valsartan 80 mg and metformin
Metformin
Sponsored by
Nantou Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantou Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Valsartan and metformin

Metformin only

Arm Description

Outcomes

Primary Outcome Measures

Serum glycosylated hemoglobin A1c
Change in serum glycosylated hemoglobin A1c of the participants

Secondary Outcome Measures

Plasma lipid fractions
Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Blood pressure
Change in systolic blood pressure and diastolic blood pressure

Full Information

First Posted
January 11, 2021
Last Updated
January 11, 2021
Sponsor
Nantou Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04707508
Brief Title
Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nantou Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valsartan and metformin
Arm Type
Experimental
Arm Title
Metformin only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Valsartan 80 mg and metformin
Intervention Description
Valsartan 80 mg once daily in addition to metformin monotherapy
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin monotherapy
Primary Outcome Measure Information:
Title
Serum glycosylated hemoglobin A1c
Description
Change in serum glycosylated hemoglobin A1c of the participants
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Plasma lipid fractions
Description
Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Time Frame
24 weeks
Title
Blood pressure
Description
Change in systolic blood pressure and diastolic blood pressure
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Chung Cheng, MD
Organizational Affiliation
Nantou Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantou Christian Hospital
City
Nantou City
State/Province
Nantou County
ZIP/Postal Code
540001
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32175717
Citation
Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
Results Reference
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PubMed Identifier
30934934
Citation
Nehme A, Zouein FA, Zayeri ZD, Zibara K. An Update on the Tissue Renin Angiotensin System and Its Role in Physiology and Pathology. J Cardiovasc Dev Dis. 2019 Mar 29;6(2):14. doi: 10.3390/jcdd6020014.
Results Reference
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PubMed Identifier
30371168
Citation
Joseph JJ, Echouffo Tcheugui JB, Effoe VS, Hsueh WA, Allison MA, Golden SH. Renin-Angiotensin-Aldosterone System, Glucose Metabolism and Incident Type 2 Diabetes Mellitus: MESA. J Am Heart Assoc. 2018 Sep 4;7(17):e009890. doi: 10.1161/JAHA.118.009890.
Results Reference
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PubMed Identifier
28191524
Citation
Das UN. Renin-angiotensin-aldosterone system in insulin resistance and metabolic syndrome. J Transl Int Med. 2016 Jun 1;4(2):66-72. doi: 10.1515/jtim-2016-0022. Epub 2016 Jul 7.
Results Reference
background
PubMed Identifier
21738773
Citation
Mor A, Aizman E, George J, Kloog Y. Ras inhibition induces insulin sensitivity and glucose uptake. PLoS One. 2011;6(6):e21712. doi: 10.1371/journal.pone.0021712. Epub 2011 Jun 29.
Results Reference
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Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

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