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Biguanide
Metformin for Muscle Health in Older Adults
Phase < 1
Waitlist Available
Led By Micah Drummond
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60y and older
Be older than 18 years old
Must not have
Personal history of cardiovascular disease
Vascular disease or risk factors of peripheral atherosclerosis (e.g., uncontrolled hypertension, obesity, diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in muscle size from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Awards & highlights
Summary
This trial investigates whether metformin can help prevent muscle loss and insulin resistance in healthy older adults who are bedridden.
Who is the study for?
This trial is for healthy older adults aged 60 and above who can consent to participate. They must not have serious health issues like uncontrolled diseases, recent cancer (except basal cell carcinoma), kidney or liver disease, respiratory problems, cardiovascular conditions, or be on certain medications like anticoagulants.
What is being tested?
The study tests if Metformin helps maintain muscle and metabolic health in bedridden older adults. Participants will either receive Metformin or a placebo while undergoing bed rest. Some participants will only take the assigned treatment during a two-week run-in period before bed rest.
What are the potential side effects?
Metformin may cause side effects such as digestive upset (nausea, diarrhea), low blood sugar levels especially when combined with other diabetes medication, vitamin B12 deficiency over long-term use which could lead to anemia or neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of heart disease.
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I have vascular disease or risk factors like high blood pressure, obesity, or diabetes.
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My thyroid and blood sugar levels are under control.
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My kidney function is impaired (creatinine > 1.5mg/dL).
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I am currently on blood thinners like Coumadin or heparin.
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I do not have HIV or hepatitis B or C.
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I am currently on a diet to lose weight or my BMI is over 30.
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I have liver or respiratory issues.
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I have had a gastrointestinal bleed in the last year.
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I have cancer or was treated for cancer, other than skin cancer, less than a year ago.
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I have had a stroke that affected my ability to move.
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My blood pressure is not higher than 160/100.
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I have been diagnosed with depression based on the GDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in insulin sensitivity from baseline to 5-days of bed rest will be compared between groups after 5 days of bed rest
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin sensitivity
Muscle size
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin (Bed Rest)Experimental Treatment1 Intervention
Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). During bed rest, participants will be given 1 gram of metformin two times a day (morning and evening). This dosage and frequency will occur during four consecutive days of bed rest.
Group II: Metformin (2 week run-in only)Experimental Treatment1 Intervention
Metformin will be given to participants incrementally during a 2 week run in period such that they will receive the clinical dose (2 grams per day). These participants will not participate in the bed rest portion of the protocol.
Group III: Placebo (2 week run-in only)Placebo Group1 Intervention
Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. These participants will not participate in the bed rest portion of the protocol.
Group IV: Placebo (Bed Rest)Placebo Group1 Intervention
Placebo will be given to participants incrementally during a 2 week run in period such that they will receive the same amount of pills as the experimental group. During bed rest, participants will be given the same amount of pills and given at the same time of day (morning and evening) as the experimental group. This strategy will occur during four consecutive days of bed rest.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,130 Previous Clinical Trials
1,793,507 Total Patients Enrolled
5 Trials studying Insulin Resistance
168 Patients Enrolled for Insulin Resistance
Micah DrummondPrincipal Investigator - University of Utah
University of Utah
4 Previous Clinical Trials
141 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are living independently before being admitted.I have a history of heart disease.I have vascular disease or risk factors like high blood pressure, obesity, or diabetes.You are unable to stop smoking for the entire study.Your blood hemoglobin or hematocrit levels are too low.I am part of the bed rest study group.You have traveled on an airplane for more than 4 hours in the past week.I am currently using estrogen products, but not vaginal creams.My thyroid and blood sugar levels are under control.My kidney function is impaired (creatinine > 1.5mg/dL).I am at risk for blood clots due to family history or high blood counts.I am currently on blood thinners like Coumadin or heparin.I am 60 years old or older.I do not have HIV or hepatitis B or C.I am currently on a diet to lose weight or my BMI is over 30.I have liver or respiratory issues.I have had a gastrointestinal bleed in the last year.I have cancer or was treated for cancer, other than skin cancer, less than a year ago.I have had a stroke that affected my ability to move.My blood pressure is not higher than 160/100.I have been diagnosed with depression based on the GDS.I haven't taken long-term steroids or growth hormones recently.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin (Bed Rest)
- Group 2: Metformin (2 week run-in only)
- Group 3: Placebo (2 week run-in only)
- Group 4: Placebo (Bed Rest)
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