Trial Outcomes & Findings for Genomic Outcomes of Metformin (NCT NCT02986659)
NCT ID: NCT02986659
Last Updated: 2023-11-18
Results Overview
Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
baseline through 12 weeks
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Metformin Then Placebo
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
First Intervention Period
STARTED
|
15
|
15
|
|
First Intervention Period
COMPLETED
|
11
|
13
|
|
First Intervention Period
NOT COMPLETED
|
4
|
2
|
|
Second Intervention Period
STARTED
|
11
|
13
|
|
Second Intervention Period
COMPLETED
|
11
|
7
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Metformin Then Placebo
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
First Intervention Period
Adverse Event
|
3
|
1
|
|
First Intervention Period
Lost to Follow-up
|
1
|
0
|
|
First Intervention Period
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention Period
Adverse Event
|
0
|
6
|
Baseline Characteristics
Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
Baseline characteristics by cohort
| Measure |
Metformin Then Placebo
n=15 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=15 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.07 years
STANDARD_DEVIATION 3.58 • n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
71.67 years
STANDARD_DEVIATION 4.13 • n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
71.4 years
STANDARD_DEVIATION 3.80 • n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
7 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
13 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
5 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
10 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
12 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
23 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=12 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
0 Participants
n=23 Participants • Total number of patients enrolled was 30, but 7 patients did not complete at least one of the two intervention periods. Numbers in baseline analysis includes only the subjects who completed.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: baseline through 12 weeksPopulation: Numbers differ from baseline due to subject withdraw or lost to follow up
Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay.
Outcome measures
| Measure |
Metformin Then Placebo
n=11 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=12 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Eigengene Scores
|
.035 Eigen Score
Standard Deviation .24
|
-0.032 Eigen Score
Standard Deviation .35
|
PRIMARY outcome
Timeframe: baseline through 24 weeksPopulation: Numbers differ from baseline due to subject withdraw or lost to follow up
Part of blood sample analysis will give results for Individual methylation sites and transcripts, especially the eigengenes of autophage, oxidative phosphorylation and protein synthesis networks Methylomic and transcriptomic profiles in monocytes. All of the results for these measures will be aggregated into an eigengene score. The eigengene score is a summary measure of a group of correlated genes. This score may indicate status of a biological function. In this analysis, the observed range of values were from -0.48 to 0.66. A lower score means downregulation of the gene group, while a higher score upregulation. No theoretical minimum or maximum value exist for this assay.
Outcome measures
| Measure |
Metformin Then Placebo
n=10 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=6 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Eigengene Scores
|
.011 Eigen Score
Standard Deviation .28
|
-0.018 Eigen Score
Standard Deviation .36
|
SECONDARY outcome
Timeframe: baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Macroautophagy is a process of wrapping cellular components inside autophagosomes and delivering them to lysosomes for degradation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksPopulation: Unable to collect and analyze these measures due to lack of funding--samples were not collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through 12 weeksPopulation: Changes in population due to withdraw/loss to follow up
Score ranges from 0 (low physical function) to 12 (high physical function).
Outcome measures
| Measure |
Metformin Then Placebo
n=11 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=12 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Expanded Short Physical Performance Battery (eSPPB)
|
.45 score on a scale
Standard Deviation .82
|
.27 score on a scale
Standard Deviation 1.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 12 weeks through 24 weeksPopulation: Changes in population due to withdraw/loss to follow up
Score ranges from 0 (low physical function) to 12 (high physical function).
Outcome measures
| Measure |
Metformin Then Placebo
n=10 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=6 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Expanded Short Physical Performance Battery (eSPPB)
|
-.010 score on a scale
Standard Deviation 0.74
|
0.00 score on a scale
Standard Deviation 0.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks, 12 weeks through 24 weeksThe Nottingham power rig evaluates mean unilateral leg muscle power
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksmeasurement of the amount of static force that the hand can squeeze
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeksPopulation: Changes in participant numbers are due to due to withdraw/loss to follow up
Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function).
Outcome measures
| Measure |
Metformin Then Placebo
n=11 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=12 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA)
|
-0.091 score on a scale
Standard Deviation 2.02
|
0.91 score on a scale
Standard Deviation 1.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks through 24 weeksPopulation: Changes in participant numbers are due to due to withdraw/loss to follow up
Change in score. Score ranges from 0 (low cognitive function) to 30 (high cognitive function).
Outcome measures
| Measure |
Metformin Then Placebo
n=10 Participants
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months. Will then cross over to 3 months on placebo.
Metformin
Placebo
|
Placebo Then Metormin
n=6 Participants
Dietary Supplement: Placebo with Methylcellulose capsules. Treatment with placebo will be initiated at a dose of a half pill taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two pills, one in the morning and one at night for the remainder of the 3 months. After 3 months on placebo, participants will then cross over to 3 months of metformin as described in the other arm.
Metformin
Placebo
|
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA)
|
1.90 score on a scale
Standard Deviation 1.60
|
0.50 score on a scale
Standard Deviation 1.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksMAT-sf is a tool for assessing self-perception of mobility. The possible range of score is from 30 to 80 with lower score indicating lower perception of mobility.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksThe PAT-D is a self-administered questionnaire which consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons".
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 12 weeks and 12 weeks through 24 weeksAmount of medication expected to be taken vs. amount participant actually takes.
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=30 participants at risk
Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months.
|
Placebo
n=30 participants at risk
Placebo will be given for 3 months.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal--Nausea/Diarrhea
|
23.3%
7/30 • Number of events 7 • Baseline through week 24
|
0.00%
0/30 • Baseline through week 24
|
|
General disorders
Itching
|
3.3%
1/30 • Number of events 1 • Baseline through week 24
|
0.00%
0/30 • Baseline through week 24
|
|
Cardiac disorders
Palpitation
|
3.3%
1/30 • Number of events 1 • Baseline through week 24
|
0.00%
0/30 • Baseline through week 24
|
|
Musculoskeletal and connective tissue disorders
Ataxia
|
0.00%
0/30 • Baseline through week 24
|
3.3%
1/30 • Number of events 1 • Baseline through week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place