UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031070 |
|---|---|
| Receipt number | R000035484 |
| Scientific Title | Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2020/03/31 12:07:41 |
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Basic information
Public title
Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols
Acronym
Randomized prospective study for perioperative diabetes control within enhanced recovery after surgery (ERAS) protocols
Scientific Title
Efficacy and safety of liraglutide for perioperative blood glucose control in diabetic subjects within enhanced recovery after surgery (ERAS) protocols
Scientific Title:Acronym
Randomized prospective study for perioperative diabetes control within enhanced recovery after surgery (ERAS) protocols
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of liraglutide, a GLP-1RAg, for perioperative glycemic control in type 2 diabetes patients undergoing elective surgery with ERAS protocols in a randomized prospective study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
blood glucose fluctuation
Key secondary outcomes
insulin dosage and days prescribed for the correction of elevated blood glucose levels, frequency of hypoglycemic events, tolerance,changes in lean body mass, changes in body fat and visceral fat area
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
perioperative periods, liraglutide 0.9mg
Interventions/Control_2
insulin therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (age 20 and above) with type 2 diabetes25 who received at least 3 months of previous antidiabetic treatment, had values of BMI over 20 kg/m2 inclusive with HbA1c 6.0% and above who were scheduled to undergo elective surgery within ERAS protocols were eligible
Key exclusion criteria
Patients who were to undergo gastrointestinal or neurosurgical procedures were excluded. Patients who tested positive for anti-GAD (glutamate decarboxylase) antibodies or with elevated ALT (2 times upper normal range) were excluded from the study. Patients with autonomic neuropathy or recurrent severe hypoglycemia were also excluded.
Patients who had been administered any drug except for oral antidiabetic drugs (OADs), which could interfere with glucose level or bodyweight (i.e. systemic corticosteroids, orlistat or sibutramine), were also excluded. Patients who had been administered sGLT-2 inhibitor or thiazolidinediones were excluded because these medicines could interfere with accurate bodyweight changes
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shizuka |
| Middle name | |
| Last name | Kaneko |
Organization
Takatsuki Redcross Hospital
Division name
Diabetes, endocrinology and life-related disease
Zip code
569-1096
Address
1-1-1 Abuno Takatsuki Osaka, Japan
TEL
072-696-0571
skayamoe@takatsuki.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kaneko |
| Middle name | |
| Last name | Shizuka |
Organization
Takatsuki Redcross Hospital
Division name
Diabetes, endocrinology and life-related disease
Zip code
569-1096
Address
1-1-1 Abuno Takatsuki Osaka, Japan
TEL
072-696-0571
Homepage URL
skayamoe@takatsuki.jrc.or.jp
Sponsor or person
Institute
Takatsuki redcross hospital
Institute
Department
Personal name
Funding Source
Organization
JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takatsuki Red Cross Hospital
Address
1-1-1 Abuno Takatsuki,Osaka
Tel
0726960571
kensyu@takatsuki.jrc.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本赤十字社 高槻赤十字病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30537714
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30537714
Number of participants that the trial has enrolled
100
Results
Liraglutide was shown to be a more effective option than insulin therapy because (1) glycemic levels were more stable; (2) the number of patients requiring additional insulin according to the insulin sliding scale was significantly smaller (p = 0.005); (3) the insulin dosage required on the day of surgery was significantly smaller (p = 0.004); (4) the additional insulin volume required was significantly less for patients throughout the perioperative period (p = 0.001).
Results date posted
| 2019 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty nine subjects (male 24, age 67.2 +/- 10.2 years, disease duration 10.1 +/- 9.4 years, HbA1c 7.12 +/- 0.96%) were prescribed liraglutide, and 41 (male 14, age 70.9 +/- 8.5 years, disease duration 14.6 +/- 10.2 years, HbA1c 7.78 +/- 1.23%) were administered insulin therapy before elective surgeries (Fig. 2). Surgeries comprised orthopedic (34 vs. 35 cases), thoracic(6 vs. 4 cases), and urological (5 vs. 1 cases) procedures for patients receiving liraglutide orinsulin therapy, respectively (Table 1). Subjects undergoing otolaryngological (n = 2), hepatic resection (n = 1), and gynecological (n = 1) surgeries were administered liraglutide, while
those undergoing breast surgery (n = 1) were administered insulin therapy (Table 1). General anesthesia (with/without epidural anesthesia, infiltration anesthesia, or a nerveblock) was administered to 46 subjects (93.9%) with liraglutide therapy and 38 (92.7%) with insulin therapy, respectively, and spinal or epidural anesthesia to the remaining 3 (6.1%) and 2 subjects, respectively (7.3%).
Participant flow
Three out of 100 eligible subjects who were screened were excluded because they did not meet the inclusion criteria. Informed consent was obtained from 97 adult T2D patients who were scheduled to undergo elective surgery within ERAS protocols. Ninety-seven individuals
were randomized. Seven subjects were subsequently excluded from the present study for the following reasons, 1 patient who was allocated to the insulin treatment group retracted his/her agreement. Two patients withdrew from insulin therapy because blood glucose levels decreased, and there was an increase in the risk of hypoglycemia due to the continuation of insulin therapy. Patients elected to discontinue insulin therapy, 1 patient was moved to another hospital for surgery and withdrew, and 1 withdrew because of an inability to consume food due to vomiting and nausea associated with anesthesia after surgery. Insulin therapy was stopped. Two patients did not undergo orthopedic surgery due to symptom improvements as a result of decreases in their body weights. Therefore, 90 subjects were ultimately
analyzed.
Adverse events
Hypoglycemic events were observed in none of the liraglutide group and in 5 subjects
(12.2%) in the insulin group. Gastrointestinal adverse events, typified by mild and tolerable nausea, were observed in 3 (6.1%) subjects in the liraglutide group and in none of the insulin group. Delayed wound healing, infection, or other complications were not observed in patients receiving either of the therapies.
Outcome measures
Glycemic fluctuations, hypoglycemic events, the number of days and insulin, dosages prescribed according to insulin sliding therapy, and perioperative complications were analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 23 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 23 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035484
