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Metformin - ClinicalTrials.gov

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Last Updated: 23 June 2022

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Metformin in Alzheimer's Dementia Prevention

Logical Memory IIa's free recall of one short story that contains 25 bits of information will be released immediately after being read aloud to the subject and again after a 30-minute delay. Total bits of information from the story that were recalled immediately and after the delay period are recorded. The Digit-Symbol Substitution Test is a subset of the WAIS-R's Digit Symbol Substitution Test. The test consisted of 110 small blank squares cut in 7 rows with 1 of 9 numbers randomly printed above each blank square. The MMSE is rated according to a score that indicates less achievement and greater cognitive impairment. Part A of the Trail-Making Test: This examination of visuoperceptive ability, attention, and speed is based on 25 circles distributed over a white sheet of 8 1/2" X 11" paper that are numbered. In an ascending order, the participant is directed to connect the circles with a pencil line as quickly as possible. Part B of the Trail-Making Test Part B: This measure of visuoperceptive ability, attention, and set-shifting ability tests involves 25 circles distributed over a white sheet of 8 1/2" X 11" paper that are either numbered or contain letters. When alternating between numbers and letters in an ascending order, the participant is encouraged to connect the circles with a pencil line as quickly as possible. ADCS-ADL-PI: The ADCS-ADL-PI was created in the ADCS Prevention Instruments Trial, and it demonstrated some of the following abilities: ADCS-ADL-PI: The ADCS-ADL-PI was developed in the ADCS Prevention Instruments Trial. The MAC-Q questionnaire is made up of six items. Questionnaire on Memory Complaint (Question) : There are six items on the MAC-Q. The first five items pertain to specific situations that are regularly reported as troubling for those with declining memory, while the last measure broadly measures overall self-perceived memory loss. The criteria for dementia diagnosis will include evidence of cognitive impairments, evidence of impairment in professional or occupational roles, and evidence of cognitive and social occupation decline. Following participants' permission, are deemed eligible, and complete the baseline survey, the metformin/placebo dose will be increased from 500 mg a day to a maximum of 2,000 mg a day. The metformin tablets are taken together in a single dose and are typically only recommended once at night. Participants will have in-person visits every ten days to check on their drug/placebo tolerance. Participants will be invited to have a baseline brain MRI without comparison. Brain 3T MRI will be performed in 186 participants from both locations throughout the country, according to the company. We're hoping that brain 3T MRI will be performed in 186 participants across all sites. Amyloid PET imaging will be obtained using 18F-Florbetaben. Tau PET acquisition will involve injection of 10 mCi of MK6240 with MRI from 90-110 mins after CT or transmission scan. 1086. To track adverse events, we'll use the ADCS Adverse Event Checklist to track adverse events. The only difference is that we will only test TSH and RPR at baseline. Participants who underwent baseline amyloid PET will be allowed to repeat the PET at 24 months, according to Brain Amyloid PET. Participants who underwent baseline Tau PET will be eligible to repeat the PET at 24 months.

Source link: https://clinicaltrials.gov/ct2/show/NCT04098666


Oral Metformin for Treatment of ABCA4 Retinopathy

Oral Metformin for Treatment of ABCA4 Retinopathy: ABCA4 Retinopathy is a progressive retinal dystrophy that results in retinal pigment epithelium and photoreceptor degeneration, resulting in central visual loss. A treatment that either reduces the risk of lipofuscin accumulation or increases the clearance of lipofuscin in the RPE may help to avoid the degeneration of this disease. This study was conducted in the hope of reducing the incidence of change in photoreceptor degeneration in ABCA4 retinopathy, including oral metformin. Endpoints: Primary Endpoint: The difference in the growth rate of square-root transformed area of EZ band loss between the pre-treatment phase and the 24 month metformin treatment phase is evident in this respect. Participants in the NEI ABCA4 Natural History study, 12-EI-0203, will primarily be recruited from the population of participants with Stargardt disease currently enrolled in the NEI ABCA4 Natural History study, 12-EI-0203, although others from outside this research will be considered if they have sufficient supporting data to meet the inclusion criteria. Participants in Phase I/II of Sites/Facilities Enrolling Participants: Participants will be seen at the NIH Clinical Center and University of Michigan Kellogg Eye Center. This is a multi-center center, Phase I/II, prospective, open-label research to determine metformin as a potential treatment to reduce the risk of photoreceptor degeneration in ABCA4 retinopathy.

Source link: https://clinicaltrials.gov/ct2/show/NCT04545736


Metformin to Prevent Inactivity-induced Loss of Muscle Health During Aging

In comparison to muscle and metabolic changes, we have found an increase in skeletal muscle inflammatory inflammation, impaired glucose uptake signaling, and an increase of enzymes related to de novo ceramide biosynthesis in healthy older adults with our bed rest studies. We have found that with our bed rest studies in healthy older adults that in addition to muscle and metabolic changes, increased skeletal muscle contraction, impaired glucose uptake signaling, and an increase in enzymes related to de novo ceramide biosynthesis. Metformin therapy has been shown to increase insulin sensitivity and attenuate muscle loss in insulin resistant adults by a process that may require ceramide synthesis. Metformin therapy in healthy older adults during bedrest may attenuate inflammation, insulin resistance, thigh muscle loss, and muscle changes as a result of muscle loss. We also assume that skeletal muscle ceramide levels, which was higher in older adults, is a contributing factor to insulin resistance with bed rest. We've also suggested that testing if daily metformin therapy in older adults during 5 days of bed rest will reduce intramuscular ceramide accumulation, insulin resistance, and decrease in thigh muscle lean mass. We would also like to determine if 5-days bed rest in older adults in the placebo group raises skeletal muscle ceramide levels and whether this are in turn associated with insulin resistance. If daily metformin therapy during 5 days of bed rest in elderly adults can raise skeletal muscle glucose uptake cell signaling, decrease muscle inflammation, and ceramide biosynthesis signaling, the test will show. Determine if metformin enhances muscle size and strength, as well as insulin sensitivity 7 days after bedrest.

Source link: https://clinicaltrials.gov/ct2/show/NCT03107884


Metformin for Chemoprevention of Lung Cancer in High Risk Obese Individuals

In overweight and obese people at high risk of lung cancer, we'll investigate the effect of metformin therapy on the expression of programmed cell death protein 1 on airway regulatory T cells. During the wait period, an estimated PD-1 expression of pulmonary Tregs in Cohort B increased by estimated PD-1 change. To investigate the effect of metformin on circulating immune cell subsets of blood. To investigate the effects of metformin on the immune profile of pulmonary parenchyma portrayed by bronchoalveolar lavage bronchoalveolar lavage. In the absence of unacceptable toxicity, participants are able to participate in metformin extended release orally for 26 weeks.

Source link: https://clinicaltrials.gov/ct2/show/NCT04931017


Endometrial Cancer Recurrence in Patients Taking Metformin

Medical records are reviewed and reports obtained by the hospital's electronic medical record are analyzed. Participants are women that had definitive treatment for endometrial cancer at WellSpan York Hospital Department of Gynecologic Oncology from 2016 to 2020. Those patients with cancer recurrence have been identified. Participants who received metformin vs. those who did not are determined was compared to those that did not. It's estimated that it takes time to endometrial cancer recurrence. A statistical analysis was used to determine each of these findings between participants who took metformin versus those that did not.

Source link: https://clinicaltrials.gov/ct2/show/NCT05192850


Can Sweetened Drinks Impair Therapeutic Effects of Metformin?

The aim of this research will enroll 40 children aged 10 to 20, as well as randomize eligible participants in a 2-arm, 12-week Metformin experiment in which one arm will be randomized to receive education and advice to reduce all sweetened beverages and the other to avoid sugar-sweetened drinks. In the first visit, the investigators will perform complete assessments of physical stability and eating habits. In addition, the investigators will be able to calculate BMI based on anthropometric measurements of height and weight. Following the completion of the 12-week program, participants will fasting to determine the metformin's effects on the following: A1c, GDF15, with BMI, and 24-hour diet recall, as well as questions about hunger relief while on metformin. Participants who drink NNS beverages, according to the investigators, metformin-induced GDF15 levels would be reduced.

Source link: https://clinicaltrials.gov/ct2/show/NCT05400863


Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial

Aims The aim of the study is to conduct a random controlled trial of women with PCOS to see the results of lifestyle counseling alone and in combination with acupuncture or metformin therapy on whole body glucose homeostasis with the aim of preventing the development of type 2 diabetes. The insulin response to glucose measurement by measuring the area under the curve AUCinsulin during the oral glucose tolerance test OGTT and later glucose monitoring showed no improvement in insulin sensitivity as determined by HOMA-IR by measuring glucose tolerance during the period under the curve AUCinsulin. The Islet u03b2-cell operation and the c-peptide index, the adipokines and lipid profile, body shape and proportions, and body fat distribution are among the Islet u03b2-cell performance and the c-peptide index, as well as body size and proportions, and body fat distribution.

Source link: https://clinicaltrials.gov/ct2/show/NCT02647827


Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

The investigators want to conduct a pragmatic trial that assesses the effectiveness of lifestyle change and Metformin use in minority cultures. The investigators will first customize an established lifestyle change workshop series developed by the East Harlem Partnership for Diabetes Prevention for use in the community, tenting the population at the participating clinical centers. For the highest risk pre-diabetic patients whose hemoglobin A1c has not increased or who are morbidly obese, the investigators intend to modify the D-CLIP protocol and escalate Metformin therapy. The investigators will continue to use our existing robust research infrastructure and network at the five locations through our Eastern Caribbean Health Outcomes Research Network and now the Yale Transdisciplinary Collaborative Center for Precision Medicine, which focuses on Precision Medicine. ECHORN, a NIMHD-funded research collaboration, seeks to reduce chronic disease prevalence in USVI, PR, and the Eastern Caribbean.

Source link: https://clinicaltrials.gov/ct2/show/NCT03258723


M4OC-Prevent 2.0: Phase IIb Trial of Metformin for Oral Cancer Prevention

In the target lesion, it was difficult to determine the histological reaction to metformin hydrochloride's extended release. Patient response to metformin therapy in the target lesion. In the target lesion, metformin has the effect of cell proliferation and its molecular targets. Molecular changes in the target lesion and blood deoxyribonucleic acid have been detected by genetic analysis. Patients receive metformin hydrochloride orally for 24 weeks in the absence of disease progression or unacceptable toxicity, according to ARM I: Patients receive extended release metformin hydrochloride orally twice a week. Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity, according to ARM II: Patients receive a placebo POQD for 24 weeks.

Source link: https://clinicaltrials.gov/ct2/show/NCT05237960


Multimodal METformin and FINGER Lifestyle Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia: a Phase IIb Multi-national Randomised, Controlled Trial

The exclusion criteria analysis with the study physician will determine participants meeting the inclusion criteria. Participants will be invited to the baseline visit, where informed consent for the full study will be obtained, baseline assessment will be conducted, and participants will be randomly assigned either the FINGER 2. 0 multidomain lifestyle intervention group or a self-guided multidomain lifestyle intervention group. Participants will develop their own healthy lifestyle plan based on universal healthy lifestyle recommendations from the study physician/nurse as part of the visits as part of their individual consultations. Participants will be encouraged to attend individual consultations and group meeting sessions in connection with the four intervention areas as part of the FINGER 2. 0 project group. Both at a gym and online will be held as part of the physical fitness component. Participants in the cognitive training component will have access to an online cognitive training module for independent training sessions. 4x500 mg metformin + 2x500 mg placebo. Placebo: 4x500 million mg placebo. All participants who were randomized to the metformin/placebo groups were sent four identical tablets per day as follows: 2000 mg/day metformin 1000 mg/day; 2x500 mg metformin 1000 mg/day: 4x500 million mg metformin + 2x500 mg placebo. Participants who do not comply with the medication will be able to continue in the study either in a lower dose trial group or receiving the structured lifestyle intervention only. Participants will not be notified of which lifestyle intervention company they have been assigned and assessors for primary and secondary outcomes will be blinded to the lifestyle group allocation.

Source link: https://clinicaltrials.gov/ct2/show/NCT05109169

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions