Metformin for High Blood Sugar After Joint Replacement
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Oregon Health and Science University
Must be taking: Metformin
Disqualifiers: Advanced renal insufficiency, Liver cirrhosis, Congestive heart failure, Alcohol abuse, others
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery. The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty. Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It seems you can continue your current medication regimen, including metformin, if applicable.
What data supports the effectiveness of the drug Metformin for high blood sugar after joint replacement?
Research suggests that Metformin, commonly used for type 2 diabetes, may reduce complications after knee replacement surgery and lower the risk of hip replacement in patients with diabetes and osteoarthritis. This indicates potential benefits for managing high blood sugar after joint replacement.12345
How does the drug Metformin differ from other treatments for high blood sugar after joint replacement?
Metformin is unique because it is an oral medication that effectively lowers blood sugar without causing hypoglycemia (dangerously low blood sugar), unlike some other diabetes drugs. It is also the first-line treatment for type 2 diabetes, making it a well-established option for managing high blood sugar.678910
Eligibility Criteria
This trial is for individuals with high blood sugar who are undergoing total hip or knee replacement surgery. It's a pilot study to see if it's possible to do a larger trial on how well metformin controls blood sugar after these surgeries.Inclusion Criteria
I am between 18 and 99 years old.
I am having a hip or knee replacement surgery.
I can take pills and will follow the metformin plan, regardless of my diabetes status.
Exclusion Criteria
I have Type 1 diabetes.
Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners
I have not abused alcohol in the last 30 days.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either oral metformin hydrochloride or placebo for blood sugar control in the perioperative period of total joint replacement surgery
3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of surgical site and periprosthetic joint infections
3 months
Treatment Details
Interventions
- Metformin (Anti-diabetic agent)
Trial OverviewThe study is testing the drug metformin against a placebo (a pill without any medicine) in patients having joint replacement surgery. The goal is to gather initial data on whether metformin helps control blood sugar levels post-surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Oral metformin hydrochloride
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet
Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Glucophage for:
- Type 2 diabetes
🇺🇸 Approved in United States as Glucophage for:
- Type 2 diabetes
🇨🇦 Approved in Canada as Glucophage for:
- Type 2 diabetes
🇯🇵 Approved in Japan as Glucophage for:
- Type 2 diabetes
🇨🇳 Approved in China as Glucophage for:
- Type 2 diabetes
🇨🇭 Approved in Switzerland as Glucophage for:
- Type 2 diabetes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science UniversityLead Sponsor
References
Metformin use and associated risk of total joint replacement in patients with type 2 diabetes: a population-based matched cohort study. [2023]It is uncertain whether metformin use is associated with reduced risk of joint replacement in patients with type 2 diabetes mellitus. We aimed to establish whether metformin use was associated with a reduced risk of total knee replacement (TKR) or total hip replacement (THR) among these patients.
Metformin Reduces the Risk of Total Hip Arthroplasty in Elderly Patients with Hip Osteoarthritis and Type 2 Diabetes Mellitus. [2023]To assess if metformin could reduce the risk of total hip arthroplasty (THA) in elderly patients with hip osteoarthritis and type 2 diabetes (T2DM).
Development of Osteoarthritis in Adults With Type 2 Diabetes Treated With Metformin vs a Sulfonylurea. [2023]Metformin may have a protective association against developing osteoarthritis (OA), but robust epidemiological data are lacking.
Preoperative High-Dose Methylprednisolone and Glycemic Control Early After Total Hip and Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2019]To evaluate the effect of a single preoperative dose of 125 mg methylprednisolone (MP) on glycemic homeostasis early after fast-track total hip and knee arthroplasty.
Metformin Use Is Associated with Fewer Complications in Patients with Type-2 Diabetes Undergoing Total Knee Arthroplasty: A Propensity Score-Matched Analysis. [2023]Diabetes is a well-established risk factor for complications following total knee arthroplasty (TKA), and the incidence of type-2 diabetes is increasing. Metformin is considered first-line therapy for type-2 diabetes and has been shown to reduce all-cause mortality and to possess anti-inflammatory properties. The impact of metformin use as it relates to outcomes following TKA is unknown. The purpose of this study was to investigate this relationship.
Rosiglitazone and pioglitazone: new preparations. Two new oral antidiabetics both poorly assessed. [2022](1) Treatment of type 2 (non insulin-dependent) diabetes is based on lifestyle measures and management of cardiovascular risk. (2) The reference first-line drug therapy for type 2 diabetes, when drug therapy is needed, is single-agent treatment with metformin (a biguanide) for overweight patients, or with glibenclamide (a glucose-lowering sulphonylurea) for other patients. (3) If monotherapy fails to control blood glucose levels adequately, most clinical guidelines then recommend a combination of metformin with a glucose-lowering sulphonylurea, although the few available comparative clinical data raise the possibility of excess mortality with this treatment. (4) Rosiglitazone and pioglitazone (glitazones that reduce insulin resistance) have been authorized in the European Union for combination with a glucose-lowering sulphonylurea (for patients in whom metformin is ineffective or poorly tolerated) or with metformin (for obese patients). (5) None of the available trials of rosiglitazone and pioglitazone include data on mortality or morbidity. (6) There are fewer data on pioglitazone than on rosiglitazone. (7) According to short-term comparative trials, rosiglitazone and pioglitazone are more effective than placebo on blood glucose levels. Combinations of rosiglitazone or pioglitazone with metformin or with glucose-lowering sulphonylureas have not been compared with the metformin + glucose-lowering sulphonylurea combination or with insulin. (8) Rosiglitazone and pioglitazone frequently cause weight gain. (9) Pioglitazone has a slightly favourable effect on lipid profiles, unlike rosiglitazone, which increases LDL-cholesterol levels. (10) The main side effect of rosiglitazone and pioglitazone is sodium and water retention, which can provoke oedema, anaemia (by haemodilution), and even heart failure. Rosiglitazone and pioglitazone are also hepatotoxic. (11) Combining rosiglitazone with insulin is contraindicated, owing to the increased risk of heart failure. The same applies to pioglitazone. (12) In practice, neither rosiglitazone nor pioglitazone has a place in the management of type 2 diabetes, except in the context of strictly controlled long-term comparative clinical trials.
A randomized, parallel group, double-blind, multicentre study comparing the efficacy and safety of Avandamet (rosiglitazone/metformin) and metformin on long-term glycaemic control and bone mineral density after 80 weeks of treatment in drug-naïve type 2 diabetes mellitus patients. [2022]The purpose of this study was to evaluate if superior glycaemic control could be achieved with Avandamet® (rosiglitazone/metformin/AVM) compared with metformin (MET) monotherapy, and if glycaemic effects attained with AVM are durable over 18 months of treatment. Bone mineral density (BMD) and bone biomarkers were evaluated in a subgroup of patients.
Diabetes update: new drugs to manage type 2 diabetes. [2022]Metformin is the first-line treatment for patients with diabetes because it reduces mortality rates. If metformin is contraindicated or is not tolerated, any one of the other available antihyperglycemic drugs may be used as monotherapy. These drugs are equally effective for glucose control, lowering A1c by approximately 1%. Evidence of their benefit for reducing mortality or morbidity, or improving health-related quality of life is lacking. A sulfonylurea, pioglitazone, or exenatide can be added to maximally dosed metformin if additional glycemic control is necessary. Sulfonylureas and pioglitazone often cause weight gain. The combination of metformin plus a sulfonylurea is associated with a greater risk of hypoglycemia and mortality than the combination of metformin and a thiazolidinedione (ie, glitazone). Thiazolidinediones are contraindicated in patients with severe heart failure or liver disease. Newer drug classes target incretin, the hormone that stimulates food-dependent insulin secretion. The incretin mimetic exenatide, a high-cost injectable drug, is similar to metformin for reduction of A1c and body mass index. Incretin-enhancing dipeptidyl-peptidase 4 inhibitors (ie, gliptins) are inferior to metformin for lowering A1c and body mass index; little is known about their effect on all-cause mortality. Fixed combination products might improve ease of use and adherence; they might also reduce cost and risk of adverse effects.
Metformin: a biguanide. [2013]Metformin is an effective agent in the oral treatment of non-insulin-dependent diabetes mellitus and does not cause hypoglycemia like the sulfonylureas. This drug is safe provided the cautions and contraindications are followed and the patient is monitored for hepatic and renal function. Metformin is used extensively outside the United States in the treatment of type II diabetes and recently was approved by the FDA for marketing under the brand name of Glucophage.
Glucose-lowering treatment of type 2 diabetes. Part II--Glucose-lowering drugs after metformin: a choice based largely on adverse effects. [2022]Metformin alone is the glucose-lowering drug of first choice for patients with type 2 diabetes. None of the other glucose-lowering drugs available in 2014 have any proven efficacy in preventing diabetes complications. How important are adverse effects in the choice of glucose-lowering alternatives to metformin for patients with type 2 diabetes? What about their effects on HbA1c levels? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology. Sulphonylureas have been in use for many years. These drugs lower HbA1c levels by an average of 1.5% when used alone, and by 0.8% to 1% when added to metformin. All sulphonylureas can cause dose-related hypoglycaemia. Available data do not rule out a tangible increase or decrease in cardiovascular mortality among patients treated with sulphonylureas. Comparative data suggest that the combination of metformin + sulphonylurea increases overall mortality. Human insulins have also been in use for many years. A daily injection of long-acting insulin, added to on-going oral glucose-lowering therapy, lowers HbA1c by 0.7% to 2.5% on average but causes weight gain and increases the risk of hypoglycaemia. It cannot be ruled out that insulin may increase the risk of certain cancers. Alpha-glucosidase inhibitors have a weak glucose-lowering effect. The average decline in HbA1c is about 0.7%, which is not sufficient to offset the gastrointestinal disorders caused by these drugs. The glucose-lowering effect of repaglinide is similar to that of sulphonylureas. Repaglinide can cause hypoglycaemia, particularly when co-administered with inhibitors of some cytochrome P450 isoenzymes. Glitazones have a clearly unfavourable harm-benefit balance, potentially causing fractures, heart failure, other cardiovascular events, bladder cancer. Gliptins lower HbA1c by 0.7% on average but can provoke anaphylactic reactions, Stevens-Johnson syndrome, and infections. Saxagliptin may increase the risk of fractures and heart failure. The long-term adverse effects of gliptins are poorly documented and may include an increased risk of pancreatic cancer. These risks are not offset by any proven clinical efficacy; patients should therefore not be exposed to these drugs. When they are combined with metformin, two injectable GLP-1 analogues, exenatide and liraglutide, have a glucose-lowering potency similar to one or two daily insulin injections. They have the advantage of inducing weight loss, without increasing the risk of hypoglycaemia. Gastrointestinal adverse effects such as nausea are frequent at the beginning of treatment. A possible increase in the risk of pancreatitis, pancreatic cancer and thyroid cancer has not been ruled out. Gliflozins reduce HbA1c by 0.6-0.7% on average. These drugs are already known to have a burdensome adverse effect profile despite their relatively recent market introduction. There are also safety signals concerning serious long-term adverse effects. Patients should not be exposed to these risks.