Insulin ResistanceNCT02706522
Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
A study testing Allocated to Carbohydrated group in people with Insulin Resistance and Inflammation, run by Gangnam Severance Hospital.
Trial summary
This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insulin Resistance, Inflammation, Delirium
- What is being tested?
- Allocated to Carbohydrated group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2016to 26 Jan 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing total hip replacement or total knee replacement surgery
Who cannot join
- Diabetes
- Dementia
- Gastro-esophageal reflux
- Upper gastrointestinal motility disorder
- Inflammatory bowel disease
- Intraperitoneal malignancy history
- Inability to perform cognitive function test
About this study
This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.
Read the detailed description
Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.
- Conditions
- Insulin Resistance, Inflammation, Delirium
- Being tested
- Allocated to Carbohydrated group, Allocated to Placebo group
- Medical subject headings
- Insulin Resistance, Inflammation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocated to Carbohydrated groupDietary supplement
Also called No NPO
Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
Allocated to Placebo groupDietary supplement
Also called flavored water
Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before
| Study group | Role | What they receive |
|---|---|---|
| Allocated to Carbohydrated group | Experimental | 1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to Carbohydrated group
4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. Receives: Dietary Supplement: Allocated to Carbohydrated group |
| Allocated to Placebo group | Placebo comparator | 1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to Placebo group
4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia. Receives: Dietary Supplement: Allocated to Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum S-100β level
Measured: Postoperative 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start24 Oct 2016
- Primary completion15 Nov 2016
- Study completion26 Jan 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeHee Na, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706522
- Sponsor's protocol ID
- 3-2015-0317
- Status last verified
- Aug 2017
- First submitted
- 2 Mar 2016
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT02706522
- Acronym / sponsor ID
- 3-2015-0317
- Conditions
- Insulin Resistance, Inflammation, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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.
This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.
Detailed description
Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allocated to Carbohydrated group | Experimental | Dietary Supplement: Allocated to Carbohydrated group1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Carbohydrated group 4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. |
| Allocated to Placebo group | Placebo comparator | Dietary Supplement: Allocated to Placebo group1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Placebo group 4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total hip replacement or total knee replacement surgery
Key exclusion criteria (7 listed)
- Diabetes
- Dementia
- Gastro-esophageal reflux
- Upper gastrointestinal motility disorder
- Inflammatory bowel disease
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 |
|---|---|---|
| Allocated to Carbohydrated groupAlso: No NPOPatients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. | Dietary supplement | Allocated to Carbohydrated group |
| Allocated to Placebo groupAlso: flavored waterPatients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before | Dietary supplement | Allocated to Placebo group |
Primary outcome
serum S-100β level
Time frame: Postoperative 1 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Allocated to Carbohydrated group in people with Insulin Resistance and Inflammation, run by Gangnam Severance Hospital.
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 7 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: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum S-100β level (time frame: Postoperative 1 hr). 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 4 Aug 2017.