Trial to evaluate effects of the intention to treat for insulin resistance (ITT-IR) to prevent cardiovascular events in early stages of diabetes
| ISRCTN | ISRCTN11215387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11215387 |
| Secondary identifying numbers | IRS 123456 |
- Submission date
- 01/04/2024
- Registration date
- 05/04/2024
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
To evaluate whether the intention to treat for insulin resistance (ITT-IR) can prevent cardiovascular events in diabetes patients with the early stages of treatment (early diabetes; life-style intervention/non-insulinotropic drugs/incretin drugs).
Who can participate?
Diabetes patients with the early stages of treatment (early-stage diabetes: life-style intervention/non-insulinotropic drugs/incretin drugs) at baseline, who continue to follow for more than six months at diabetes center of Wakayama Rosai Hospital.
What does the study involve?
To evaluate whether the intention to treat for insulin resistance (ITT-IR) can prevent cardiovascular events in the early-stage diabetes.
What are the possible benefits and risks of participating?
Self-monitoring determined a target may be useful for cognition of physical parameter and resultant acceptance of treatment on diet and prescription.
Following V with abdominal CT may motivate patients to increase ADL.
Preferential prescription of non-insulinotropic diabetes drugs [biguanide, α-glucosidase inhibitor, thiazolidine, or sodium glucose co-transporter 2 (SGLT2) inhibitor] and disuse of insulinotropic drugs (DPP4I, GN and SU), as far as possible, may affect the adherence of patient.
The prevalence of hypoglycemia and the progression of retinopathy may differ.
The following rate in G-I may decrease from the change of treatment policy.
Where is the study run from?
Wakayama Rosai Hospital (Japan)
When is the study starting and how long is it expected to run for?
April 2016 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Takashi Ohoshi, tks-oohoshi@wakayamah.johas.go.jp
Contact information
Public, Scientific, Principal Investigator
93-1Kinomoto
Wakayama
640-8505
Japan
 ORCID ID |
0009-0007-3498-2419 |
|---|---|
| Phone | +81 734513181 |
| tks-oohoshi@wakayamah.johas.go.jp |
Study information
| Study design | Cluster randomized open parallel controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community, Hospital, Medical and other records |
| Study type | Prevention, Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Cluster randomized parallel controlled trial to evaluate effects of the intention to treat for insulin resistance (ITT-IR) to prevent cardiovascular events in early stages of diabetes |
| Study acronym | ITT-IR trial |
| Study objectives | From the ACCORD and Steno-2 Study, it became clear that pushing glucose levels as low as possible in diabetic patients with a long duration of the condition could be harmful. It was evident that managing not just blood glucose but also other existing risk factors comprehensively was necessary to prevent cardiovascular complications. However, because of the need to address multiple risk factors in comprehensive therapy, the treatment focus became unclear. Thus, this study sought to address insulin resistance, the primary pathogenic feature of diabetes, particularly in the early stages of type 2 and possibly slowly progressive type 1. We aimed to determine whether the intention to treat insulin resistance (ITT-IR) could effectively prevent cardiovascular events in the early stages of diabetes. |
| Ethics approval(s) |
Approved 26/08/2022, Ethics committee of Wakayama Rosai Hospital (93-1 Kinomoto, Wakayama city, 640-8505, Japan; +81 734513181; ohoshi03@yahoo.co.jp), ref: 22研―06 |
| Health condition(s) or problem(s) studied | Early stages of diabetes |
| Intervention | Intervention group (G-I): The protocols of I [self-monitoring of steps, of body weight and of blood pressure (BP), following of visceral fat area (V) in abdominal obese patients, diet advise by dietitian, and preferential prescription of non-insulinotropic drugs] were recommended from baseline to 65 weeks (I-period). After I-period we continued to follow until week 272. Control group (G-C): Conventional treatment for diabetes mellitus from baseline to 272 weeks. Authors adopted cluster randomization from the complex intervention unable to mask. Of seven doctors in diabetes center, only one doctor treated patients according to “ITT-IR” policy. Researcher did not inform patients and other doctors on this policy in advance to reduce minimally influence on their mode of treatment. The ninety patients of ITT-IR (G-I) were randomly allocated and followed using intention-to-treat (ITT) analysis. |
| Intervention type | Mixed |
| Primary outcome measure | Measured using patient records at the end of study: Percutaneous coronary intervention, carotid endarterectomy, carotid artery stenting, endovascular treatment, thromboendarterectomy, coronary artery bypass grafting, ablation, implantable cardioverter defibrillator, clipping for aneurysm of intracranial arteries, amputation from gangrene, non-fatal stroke, non-fatal myocardial infarction(MI), hemodialysis, frailty, dementia, hospitalization from heart failure, death from cardiovascular causes, death from renal failure, death from frailty) |
| Secondary outcome measures | Measured using patient records at the end of study: Hospitalization from complications or comorbidities, death) |
| Overall study start date | 05/04/2016 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | G-I 88, G-C 516 |
| Total final enrolment | 757 |
| Key inclusion criteria | Diabetes patients visited outpatient clinic in Wakayama Rosai Hospital from April to June in 2016 |
| Key exclusion criteria | Cannot continue to visit our outpatient clinic |
| Date of first enrolment | 05/04/2016 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- Japan
Study participating centre
Wakayama city
640-8505
Japan
Sponsor information
Hospital/treatment centre
93-1Kinomoto
Wakayama
6408505
Japan
| Phone | +81 734513181 |
|---|---|
| tks-oohoshi@wakayamah.johas.go.jp | |
| Website | http://www.wakayamah.johas.go.jp/ |
"ROR" |
https://ror.org/00awxvj03 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Raw data are available on reasonable request to the corresponding author. All data relevant to the study are included in publication data. ohoshi03@yahoo.co.jp |
Editorial Notes
08/04/2024: Internal review.
02/04/2024: Trial's existence confirmed by Ethics committee of Wakayama Rosai Hospital.
