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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
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
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 (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.
Group IV: 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.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,566 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
Media Library
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: Placebo (Bed Rest)
- Group 2: Metformin (2 week run-in only)
- Group 3: Placebo (2 week run-in only)
- Group 4: Metformin (Bed Rest)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are enrolled in this clinical research?
"Affirmative. Data sourced from clinicaltrials.gov displays that this medical trial, which was first advertised on August 1st 2019, is still seeking out participants. The research team needs to enroll around 60 individuals across one site."
Answered by AI
Are there any other trials that have been conducted for the purpose of determining Metformin's efficacy in combination with Bed Rest?
"Currently, the use of Metformin (Bed Rest) is being studied in 170 active clinical trials, 43 of which are presently at Phase 3. Although Pittsburgh, Pennsylvania has several studies examining its effects on patients, there are 1903 other medical sites running these tests."
Answered by AI
In what cases is Metformin (Bed Rest) usually prescribed?
"Metformin (Bed Rest) is prescribed to treat exercise-induced complications, as well as type 1 diabetes mellitus, diabetic ketoacidosis and polycystic ovary syndrome."
Answered by AI
Are there any open slots available in this research program?
"Affirmative. Information available on clinicaltrials.gov affirms that this research study is actively recruiting participants, having been initially posted on the 1st of August 2019 and last updated on 17th June 2022. The trial seeks 60 volunteers to be recruited from one site."
Answered by AI
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