Metabolism DisorderNCT03033667
Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients
A study testing G group, group L and Group C in people with Metabolism Disorder, run by Cairo University.
Trial summary
Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolism Disorder
- What is being tested?
- G group, group L and Group C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).
- All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.
Who cannot join
- Patients with diabetes mellitus
- Patients on fibrates
- Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
- Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
- Patients with carbohydrate or fat intolerance
About this study
Official title: Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting
Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.
Read the detailed description
Obese patients scheduled for bypass surgery randomly assigned to three groups:
Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.
Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.
Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.
- Conditions
- Metabolism Disorder
- Being tested
- G group, group L, Group C
- Keywords
- perioperative fasting, free fatty acids, coronary bypass grfting
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G groupDietary supplement
patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L
group LDietary supplement
patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour
Group CDietary supplement
Over night fasting with no supplementation
| Study group | Role | What they receive |
|---|---|---|
| Glucose group (G group) | Experimental | patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L. Receives: Dietary Supplement: G group |
| Lipid Group (L group) | Experimental | patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L. Receives: Dietary Supplement: group L |
| Control Group (C group) | Experimental | patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am. Receives: Dietary Supplement: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution
Measured: Over an infusion period of 10 hours preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033667
- Sponsor's protocol ID
- SMOF
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03033667
- Acronym / sponsor ID
- SMOF
- Conditions
- Metabolism Disorder
- Keywords
- perioperative fasting, free fatty acids, coronary bypass grfting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Jan 2017 (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.
Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.
Detailed description
Obese patients scheduled for bypass surgery randomly assigned to three groups:
Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.
Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.
Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose group (G group) | Experimental | Dietary Supplement: G grouppatients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L. |
| Lipid Group (L group) | Experimental | Dietary Supplement: group Lpatients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L. |
| Control Group (C group) | Experimental | Dietary Supplement: Group Cpatients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).
- All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.
Key exclusion criteria (5 listed)
- Patients with diabetes mellitus
- Patients on fibrates
- Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
- Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
- Patients with carbohydrate or fat intolerance
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 |
|---|---|---|
| G grouppatients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L | Dietary supplement | Glucose group (G group) |
| group Lpatients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour | Dietary supplement | Lipid Group (L group) |
| Group COver night fasting with no supplementation | Dietary supplement | Control Group (C group) |
Primary outcome
The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution
Time frame: Over an infusion period of 10 hours preoperatively
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 27 Jan 2017.
- Individual participant dataSharing planned: Yes
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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 G group, group L and Group C in people with Metabolism Disorder, run by Cairo University.
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 2 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: finished, as of the sponsor's last update on 27 Jan 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. 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?
The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution (time frame: Over an infusion period of 10 hours preoperatively). 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 27 Jan 2017.