Insulin ResistanceNCT05540249
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
A study testing carbohydrates in people with Insulin Resistance and Diabetes Mellitus, Type 2, run by China National Center for Cardiovascular Diseases.
Trial summary
Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Resistance, Diabetes Mellitus, Type 2, Coronary Artery Bypass Surgery
- What is being tested?
- carbohydrates
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jan 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed T2DM
- Diagnosed with CAD with coronary angiography and indicated for OPCAB
- Age between 18 and 75 years old
- First operation in the morning and anesthesia induced around 8:00
- Written informed consent by the patients
Who cannot join
- Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
- Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
- Reduced LVEF (lower than 50%)
- Combined with gastroesophageal reflux
- Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
- Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
- Refuse to participate.
About this study
Official title: Effects of Pre-operative Oral Carbohydrates on Insulin Resistance and Postoperative Recovery in Diabetic Patients Undergoing Coronary Artery Bypass Grafting
Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Thus, the investigators design a randomized controlled trial investigating the impact of preoperative CHO on postoperative IR and clinical outcomes in diabetic patients undergoing cardiac surgery. The results of the study may give some clinical implications and further improve perioperative care for diabetic patients.
Read the detailed description
CHO supplement has been widely investigated in nondiabetic patients undergoing various surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients' well-being in nondiabetic patients. However, whether preoperative CHO could yield similar effects in diabetic patients remains controversial. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and few studies reported IR and postoperative recovery of diabetic patients undergoing cardiac surgery. The investigators present a prospective, single-center, single-blind, randomized, no-treatment controlled trial of preoperative CHO on diabetic patients undergoing off-pump coronary artery bypass grafting (OPCAB). A total of 62 patients will be enrolled and randomized to either Group CHO or Group control (CTRL). Patients in group CHO will receive CHO fluid containing 50 g of carbohydrates the evening before surgery (20:00-24:00) while their counterparts in Group CTRL will be fasted after 20:00 the evening before surgery. The primary endpoints are postoperative insulin resistance (IR) assessed via homeostasis model assessment (HOMA). The secondary endpoints are the potential mediators relating to IR including inflammatory factors and stress reactions assessed by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints.
- Being tested
- carbohydrates
- Keywords
- preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydratesDietary supplement
Also called Outfast
Patients will orally consume 355mL CHO after 20:00 the evening before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group CHO | Experimental | Patients in Group CHO will orally consume CHO 355ml containing 50 g of carbohydrates 8-12 hours before operation (20:00 -24:00 the evening before operation). Receives: Dietary Supplement: carbohydrates |
| Group CTRL | No intervention | Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: Before anesthesia induction
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: Immediately after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: The first morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: The second morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: The third morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: The fifth morning after surgery
Secondary outcomes (6)
Interleukin -1 (IL-1)
Inflammatory factors
Measured: The first morning after surgery
Interleukin-6 (IL-6)
Inflammatory factors
Measured: The first morning after surgery
Interleukin-8 (IL-8),
Inflammatory factors
Measured: The first morning after surgery
Interleukin-10 (IL-10),
Inflammatory factors
Measured: The first morning after surgery
Tumor necrosis fator-α (TNF-α)
Inflammatory factors
Measured: The first morning after surgery
High-sensitivity C-reactive protein (hs-CRP)
Inflammatory factors
Measured: The first morning after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (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.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wei Feng, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540249
- Sponsor's protocol ID
- 2019-ZX40
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Except for the identifying data such as patients name and admission ID, all the IPD could be available to other researchers on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Oral Carbohydrates on Insulin Resistance and Postoperative Recovery in Diabetic Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05540249
- Acronym / sponsor ID
- 2019-ZX40
- Keywords
- preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Sep 2022 (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.
Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Thus, the investigators design a randomized controlled trial investigating the impact of preoperative CHO on postoperative IR and clinical outcomes in diabetic patients undergoing cardiac surgery. The results of the study may give some clinical implications and further improve perioperative care for diabetic patients.
Detailed description
CHO supplement has been widely investigated in nondiabetic patients undergoing various surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients' well-being in nondiabetic patients. However, whether preoperative CHO could yield similar effects in diabetic patients remains controversial. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and few studies reported IR and postoperative recovery of diabetic patients undergoing cardiac surgery. The investigators present a prospective, single-center, single-blind, randomized, no-treatment controlled trial of preoperative CHO on diabetic patients undergoing off-pump coronary artery bypass grafting (OPCAB). A total of 62 patients will be enrolled and randomized to either Group CHO or Group control (CTRL). Patients in group CHO will receive CHO fluid containing 50 g of carbohydrates the evening before surgery (20:00-24:00) while their counterparts in Group CTRL will be fasted after 20:00 the evening before surgery. The primary endpoints are postoperative insulin resistance (IR) assessed via homeostasis model assessment (HOMA). The secondary endpoints are the potential mediators relating to IR including inflammatory factors and stress reactions assessed by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CHO | Experimental | Dietary Supplement: carbohydratesPatients in Group CHO will orally consume CHO 355ml containing 50 g of carbohydrates 8-12 hours before operation (20:00 -24:00 the evening before operation). |
| Group CTRL | No intervention | –Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously diagnosed T2DM
- Diagnosed with CAD with coronary angiography and indicated for OPCAB
- Age between 18 and 75 years old
- First operation in the morning and anesthesia induced around 8:00
- Written informed consent by the patients
Key exclusion criteria (7 listed)
- Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
- Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
- Reduced LVEF (lower than 50%)
- Combined with gastroesophageal reflux
- Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
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 |
|---|---|---|
| carbohydratesAlso: OutfastPatients will orally consume 355mL CHO after 20:00 the evening before surgery. | Dietary supplement | Group CHO |
Primary outcome
Peri-operative Change from baseline HOMA-IR
Time frame: Before anesthesia induction
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
Time frame: Immediately after surgery
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
Time frame: The first morning after surgery
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
Time frame: The second morning after surgery
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
Time frame: The third morning after surgery
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
Time frame: The fifth morning after surgery
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
6 secondary outcomes
Interleukin -1 (IL-1)
Time frame: The first morning after surgery
Interleukin-6 (IL-6)
Time frame: The first morning after surgery
Interleukin-8 (IL-8),
Time frame: The first morning after surgery
Interleukin-10 (IL-10),
Time frame: The first morning after surgery
Tumor necrosis fator-α (TNF-α)
Time frame: The first morning after surgery
High-sensitivity C-reactive protein (hs-CRP)
Time frame: The first morning after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: Yes. Except for the identifying data such as patients name and admission ID, all the IPD could be available to other researchers on reasonable request.
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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.
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 carbohydrates in people with Insulin Resistance and Diabetes Mellitus, Type 2, run by China National Center for Cardiovascular Diseases.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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. 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?
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?
Peri-operative Change from baseline HOMA-IR (time frame: Before anesthesia induction). The study lists 6 primary outcomes in all. 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 14 Sep 2022.