GIK Therapy for Broken Leg Bones

(MAGIK Trial)

Overseen By Matthew Kingery, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Age below 18, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a treatment called GIK (glucose-insulin-potassium) therapy for individuals with broken leg bones, specifically fractures in the femur or tibia. The goal is to determine if this therapy can reduce muscle damage and prevent complications such as severe muscle breakdown (rhabdomyolysis) and kidney issues after surgery. Participants will be divided into two groups: one will receive GIK therapy, while the other will receive a saline solution for comparison. Individuals with a femur or tibia fracture who are expected to survive more than 72 hours post-surgery may be suitable for this trial. As a Phase 2 trial, this study focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GIK therapy is likely to be safe for humans?

Research has shown that the GIK solution, containing glucose, insulin, and potassium, has been tested for safety in various medical situations. In past studies, GIK supported heart health during surgery, resulting in positive outcomes and fewer issues like irregular heartbeats. These studies suggest that GIK is generally safe for patients.

While specific information on GIK's side effects for treating leg bone injuries is lacking, the current phase 2 trial is closely examining its safety. Researchers aim to confirm the treatment's safety for a specific group of patients. Overall, existing research indicates that GIK has been used safely in other medical areas, providing some reassurance about its safety in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for broken leg bones, which often involves surgery and pain management, GIK therapy introduces a novel approach by focusing on biochemical support to improve healing. This treatment is unique because it uses a glucose-insulin-potassium (GIK) solution to potentially reduce muscle injury and support overall tissue recovery. Researchers are excited about GIK therapy as it could speed up healing by normalizing lab markers like creatinine and lactate, which are indicators of muscle and kidney health. This biochemical approach might also help prevent complications like rhabdomyolysis, making it a promising addition to traditional treatments.

What evidence suggests that GIK therapy might be an effective treatment for lower extremity trauma?

Research has shown that glucose-insulin-potassium (GIK) therapy, which participants in this trial may receive, can reduce muscle damage and improve recovery after injuries. In studies with heart patients, GIK potentially enhanced overall recovery and function. This therapy supplies essential nutrients that improve cellular function, which may protect muscles from damage and support healing. Additionally, GIK has been linked to less severe muscle breakdown and a lower risk of kidney damage from muscle injury. These findings suggest that GIK could be a promising treatment to reduce complications and improve recovery for people with broken leg bones. ^{1 2 4 5 6}

Who Is on the Research Team?

Sanjit Konda, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with femoral or tibial shaft fractures who have survived more than 72 hours after definitive fracture fixation. It's not for those under 18, pregnant women, patients with certain types of low energy fractures, prior limb weakness due to neurological conditions, pathologic fractures, or anyone with contraindications to MRI or the study medications.

Inclusion Criteria

Survival > 72 hours after definitive femur fracture fixation

I have a broken thigh bone or shin bone.

Exclusion Criteria

I survived less than 72 hours after my femur surgery.

Pregnant women as the safety of GIK therapy in pregnant women has not been studied

I have had a fracture due to my disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either GIK therapy or placebo control with monitoring of lab values for muscle injury and kidney function

Up to 1 week

Daily monitoring during hospital stay

Follow-up

Participants are monitored for muscle strength and volume, and physical function up to 52 weeks post-operation

52 weeks

Regular follow-up visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• GIK solution
• Isotonic Normal Saline Solution

Trial Overview The MAGIK trial is testing whether a glucose-insulin-potassium (GIK) solution can reduce muscle damage and kidney injury after lower extremity trauma compared to normal saline. The study will randomly assign 40 patients into two groups: one receiving GIK therapy and the other receiving saline as a control.

How Is the Trial Designed?

Group I: GIK Therapy Experimental Treatment 1 Intervention

In patients randomized to the GIK Therapy Arm, a stepwise GIK infusion process will be performed. Baseline lab values that are markers of skeletal muscle injury (CPK), acute kidney injury (creatinine), and general tissue perfusion (lactate) will be obtained within the first 30 min of arrival to the ED. Subsequently, serial CPK, creatinine, myoglobin and lactate values will be obtained at regularly scheduled intervals until a minimum of 72 hours after definitive fixation or until rhabdomyolysis is resolved and/or kidney function has normalized

Group II: Placebo Control Placebo Group 1 Intervention

Patients randomized to the control cohort will receive a normal saline infusion instead of GIK. Standard institutional ICU protocol will be used to monitor potassium and glucose levels per current standard-of-care practices and abnormal lab values will be treated accordingly per standard institutional protocols.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4043184/

PMC - PubMed Central The study drug GIK solution had 30% glucose (300 g/L), 50 units of regular insulin per liter, and 80 mEq of KCl/L, which had been shown to improve myocardial ...

2. withpower.com withpower.com/trial/phase-2-femoral-shaft-fractures-2023-ff5d1

GIK Therapy for Broken Leg Bones (MAGIK Trial) The use of systemic GIK is expected to decrease the overall amount of lower extremity muscle cell death and result in improved muscle function in the ...

3. immtx.com immtx.com/wp-content/uploads/2021/08/144.1-yr-outcome-GIK-IMMEDIATE-AJC-2014.pdf

One-Year Outcomes of Out-of-Hospital Administration of The study drug GIK solution had 30% glucose (300 g/L),. 50 U/L of regular insulin, and 80 mEq of potassium chloride per liter, which had been shown to improve ...

4. jcardcritcare.org jcardcritcare.org/to-assess-the-impact-of-glucose-insulin-and-potassium-chloride-infusions-in-patients-after-cardiothoracic-surgery-on-arrhythmias-and-outcome/

To Assess the Impact of Glucose, Insulin, and Potassium ... GIK infusion after cardiac surgery helps to minimize post-operative arrhythmias and is linked to better post-operative outcomes.

5. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/items/d58cfa67-d60a-4b19-b2bc-28fc3ce10942

Effect of Glucose–Insulin–Potassium Infusion on Mortality in ... This study seeks to measure the treatment effect of glucose—insulin—potassium (GIK) infusion on mortality in critically ill patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01384656

Effect of Glucose-insulin-potassium Solution on Myocardial ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...