Insulin ResistanceNCT03658564
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
A study testing Preoperative Oral Carbohydrate Drink in people with Insulin Resistance, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Preoperative Oral Carbohydrate Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery
Who cannot join
- Weight loss greater than 10 per cent during the previous 6 months
- Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
- Hepatic insufficiency (Child-Pugh class, ≥ B)
- Gastro-oesophageal reflux disease
- Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116000
yang z Xiao, MD,PhD, 0866-17709873399
About this study
Official title: Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial
Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.
Read the detailed description
Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.
- Conditions
- Insulin Resistance
- Being tested
- Preoperative Oral Carbohydrate Drink
- Keywords
- Insulin resistance, Diabetes mellitus, Carbohydrate
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Oral Carbohydrate DrinkDietary supplement
Patients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Oral carbohydrate | Experimental | fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes. Receives: Dietary Supplement: Preoperative Oral Carbohydrate Drink |
| Fasting | No intervention | fast from midnight the night before surgery, and no preoperative oral carbohydrate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Preoperative general well-beings before assessed with the visual analogue scale (VAS).
Measured: 1 day (preoperative period)
Secondary outcomes (1)
HOMA
Preoperative insulin resistance before and immediately after the surgery assessed with the homeostasis model assessment (HOMA)
Measured: perioperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start30 Sep 2018
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yang z Xiao, MD,PhD, Study director, 0866-17709873399
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658564
- Sponsor's protocol ID
- poster2017
- Status last verified
- Sep 2018
- First submitted
- 19 May 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial
- ClinicalTrials.gov ID
- NCT03658564
- Acronym / sponsor ID
- poster2017
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, Diabetes mellitus, Carbohydrate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.
Detailed description
Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral carbohydrate | Experimental | Dietary Supplement: Preoperative Oral Carbohydrate Drinkfast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes. |
| Fasting | No intervention | –fast from midnight the night before surgery, and no preoperative oral carbohydrate loading |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery
Key exclusion criteria (5 listed)
- Weight loss greater than 10 per cent during the previous 6 months
- Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
- Hepatic insufficiency (Child-Pugh class, ≥ B)
- Gastro-oesophageal reflux disease
- Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Oral Carbohydrate DrinkPatients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes. | Dietary supplement | Oral carbohydrate |
Primary outcome
VAS
Time frame: 1 day (preoperative period)
Preoperative general well-beings before assessed with the visual analogue scale (VAS).
1 secondary outcome
HOMA
Time frame: perioperative period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yang z Xiao, MD,PhD study director
0866-17709873399
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Oral Carbohydrate Drink in people with Insulin Resistance, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yang z Xiao, MD,PhD (0866-17709873399, xiaozhaoy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 1 day (preoperative period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.