Pre-DiabetesNCT02393573
Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
A study testing Metformin in people with Pre-Diabetes and Major Lung or Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Diabetes, Major Lung or Abdominal Surgery, Insulin Resistance
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Mar 2018
- 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
- Elective open anatomic lung resections: segmentectomy, lobectomy, bi-lobectomy
- Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- Primary or secondary lung cancer
- At least 18 years of age with
- HbA1c 5.7- 6.5 %
- Not receiving any kind of glucose lowering medication.
Who cannot join
- Already diagnosed with diabetes (Hb A1c > 6.5%)
- Are pre-diabetic receiving glucose lowering intervention ( any glucose lowering medication)
- Have renal or liver dysfunction (serum creatinine above 124 micromol/L in women and 133 micromol/L in men, bilirubin >50 micromol/L)
- will undergo extended resection of adjacent organs, chest wall resections, bronchoplasty, non-anatomic lung resections
- Will undergo Pneumonectomy
- Non-elective operations
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- Have mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis),
- Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), Chronic obstructive pulmonary disease(COPD), sepsis, morbid obesity (BMI >40 kg/m2), anemia (hematocrit < 30 %, hemoglobin <100g/L albumin < 25mg/dl)
- Have received steroids for longer than 30 days
- Have poor English or French comprehension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery
Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.
- Being tested
- Metformin, Placebo
- Keywords
- Insulin Resistance, Protein balance, Surgery, Post operative complications, metformin, Pre-diabetes, Fasting blood glucose
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Patients will take metformin for two weeks before Surgery and 2 days after the surgery
PlaceboDrug
Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin will be administered as pills to be taken orally with an initial dose of 850 mg on the first day; the dose will be increased to 850 mg every 12 hours and 850mg every 8 hours respectively on the second day and then on the days to follow up to the morning of the surgery. Metformin will be discontinued on the day of surgery and will be restarted immediately after surgery. Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo will be administered exactly in the similar way to Metformin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose
the level of plasma glucose after 6 hours of fasting
Measured: 2 weeks before surgery (pre-operative) and on the morning before the surgery and every morning after the surgery (post operative) for three days or until discharge which ever comes earlier
Secondary outcomes (6)
Change in whole body protein balance
The difference between the Pre-operative whole body protein balance( prior to metformin treatment) and the post operative whole body protein balance
Measured: 2 weeks before surgery (pre-operative) and hours after the surgery (post operative)
Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin)
Measured: at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery
glycosylated Hba1c
plasma level of glycosylated Hba1c
Measured: 2 weeks before surgery
Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat)
Measures body composition specifically fat content
Measured: 2 weeks before surgery and 48 hours after the surgery
Surgical Complications
Any complication related to the surgery with in 30 days post operation
Measured: 30 days after operation
length of hospital stay
Length of hospital stay is calculated as the total length of hospitalization from the date of admission for the purpose of surgery until the date of discharge from the hospital
Measured: Up to 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Medtronic - MITG
- Responsible party
- Principal investigator, Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Liane Feldman, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreFrancesco Carli, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393573
- Sponsor's protocol ID
- 14-264-SDR
- Status last verified
- Mar 2018
- First submitted
- 10 Feb 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02393573
- Acronym / sponsor ID
- 14-264-SDR
- Keywords
- Insulin Resistance, Protein balance, Surgery, Post operative complications, metformin, Pre-diabetes, Fasting blood glucose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Mitacs, Medtronic - MITG
- Study start
- Nov 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Mar 2015 (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.
Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin will be administered as pills to be taken orally with an initial dose of 850 mg on the first day; the dose will be increased to 850 mg every 12 hours and 850mg every 8 hours respectively on the second day and then on the days to follow up to the morning of the surgery. Metformin will be discontinued on the day of surgery and will be restarted immediately after surgery. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered exactly in the similar way to Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective open anatomic lung resections: segmentectomy, lobectomy, bi-lobectomy
- Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- Primary or secondary lung cancer
- At least 18 years of age with
- HbA1c 5.7- 6.5 %
Key exclusion criteria (10 listed)
- Already diagnosed with diabetes (Hb A1c > 6.5%)
- Are pre-diabetic receiving glucose lowering intervention ( any glucose lowering medication)
- Have renal or liver dysfunction (serum creatinine above 124 micromol/L in women and 133 micromol/L in men, bilirubin >50 micromol/L)
- will undergo extended resection of adjacent organs, chest wall resections, bronchoplasty, non-anatomic lung resections
- Will undergo Pneumonectomy
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 |
|---|---|---|
| MetforminPatients will take metformin for two weeks before Surgery and 2 days after the surgery | Drug | Metformin |
| PlaceboPatients will take Placebo pills for two weeks before Surgery and 2 days after the surgery | Drug | Placebo |
Primary outcome
Change in fasting blood glucose
Time frame: 2 weeks before surgery (pre-operative) and on the morning before the surgery and every morning after the surgery (post operative) for three days or until discharge which ever comes earlier
the level of plasma glucose after 6 hours of fasting
6 secondary outcomes
Change in whole body protein balance
Time frame: 2 weeks before surgery (pre-operative) and hours after the surgery (post operative)
Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin)
Time frame: at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery
glycosylated Hba1c
Time frame: 2 weeks before surgery
Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat)
Time frame: 2 weeks before surgery and 48 hours after the surgery
Surgical Complications
Time frame: 30 days after operation
length of hospital stay
Time frame: Up to 30 days after operation
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Liane Feldman, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Francesco Carli, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Pre-Diabetes and Major Lung or Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 23 Mar 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 Canada. 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. 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 was stopped early (reason given: Poor recruitment). 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?
Change in fasting blood glucose (time frame: 2 weeks before surgery (pre-operative) and on the morning before the surgery and every morning after the surgery (post operative) for three days or until discharge which ever comes earlier). 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 23 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.