Trial Outcomes & Findings for Improving Neuropathy and Mobility in People With Early Diabetes (NCT NCT00780559)

NCT ID: NCT00780559

Last Updated: 2021-04-09

Results Overview

Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: Six Months
• Results posted on: 2021-04-09

Participant Flow

Participants were excluded from the study prior to assignment for groups (n=12) due to failure of screening (e.g. not meeting inclusion/exclusion criteria, n=10) or declined to participate (n=2.)

Participant milestones

Measure	Tailored Diet and Physical Activity Tailored Diet and Physical Activity: Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care Standard of Care: Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Overall Study STARTED	32	40
Overall Study COMPLETED	29	33
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	Tailored Diet and Physical Activity Tailored Diet and Physical Activity: Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care Standard of Care: Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Overall Study Lost to Follow-up	2	7
Overall Study Death	1	0

Baseline Characteristics

Improving Neuropathy and Mobility in People With Early Diabetes

Baseline characteristics by cohort

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	28 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	61.81 Years STANDARD_DEVIATION 8.25 • n=5 Participants	61.03 Years STANDARD_DEVIATION 7.83 • n=7 Participants	61.38 Years STANDARD_DEVIATION 7.91 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
BMI (Body Mass Index), Categorical BMI < 30 kg/m^2	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
BMI (Body Mass Index), Categorical BMI 30 - 40 kg/m^2	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
BMI (Body Mass Index), Categorical BMI > 40 kg/m^2	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
BMI (Body Mass Index), Continuous	33.21 kg/m^2 STANDARD_DEVIATION 7.65 • n=5 Participants	30.83 kg/m^2 STANDARD_DEVIATION 7.06 • n=7 Participants	31.89 kg/m^2 STANDARD_DEVIATION 7.37 • n=5 Participants

PRIMARY outcome

Timeframe: Six Months

Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.

Outcome measures

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Six Minute Walk (6MW) Test	156.644156 feet Standard Error 35.364227	61.257846 feet Standard Error 35.840649

PRIMARY outcome

Timeframe: Baseline and 12 Months

Outcome measures

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months	188.415845 feet Standard Error 34.346235	100.559319 feet Standard Error 36.399507

SECONDARY outcome

Timeframe: 12 Months

Measure of the number of skin fibers/mm in the lower extremity (distal leg) at 12 months

Outcome measures

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Intraepidermal Nerve Fiber Density (Distal Leg)	1.28627099 fibers/mm Standard Error 0.81830712	-0.38943425 fibers/mm Standard Error 0.84781677

SECONDARY outcome

Timeframe: 12 Months

Measure of the number of skin fibers/mm in the lower extremity (proximal thigh) at 12 months

Outcome measures

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh	1.53825016 fibers/mm Standard Error 0.83395303	-0.54419990 fibers/mm Standard Error 0.87926529

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 Months

Physical Activity measured by CHAMPS provides an estimated caloric expenditure of subject based on weight and weekly physical activity, as assessed by the questionnaire. Change in physical activity is determined by the difference in daily caloric expenditure at baseline and 12 months.

Outcome measures

Measure	Tailored Diet and Physical Activity n=32 Participants Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 Participants Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale	-735.249060 kcal/day Standard Error 886.986000	296.998122 kcal/day Standard Error 937.935990

Adverse Events

Tailored Diet and Physical Activity

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tailored Diet and Physical Activity n=32 participants at risk Subjects will receive an individually tailored diet and physical activity enhancement program	Standard of Care n=40 participants at risk Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Product Issues Skin Irritation	3.1% 1/32 • Number of events 1 • Adverse event data for each participant was collected over one year per study patient, or the duration of the study for each participant. The definition of adverse events and/or serious adverse events does not differ from that which is listed here on clinicaltrials.gov. Adverse Events were collected from patient reports and phone call follow-ups.	0.00% 0/40 • Adverse event data for each participant was collected over one year per study patient, or the duration of the study for each participant. The definition of adverse events and/or serious adverse events does not differ from that which is listed here on clinicaltrials.gov. Adverse Events were collected from patient reports and phone call follow-ups.

Additional Information

Clinical Research Coordinator

University of Maryland School of Medicine

Phone: (410) 328-6583

Email: inmed@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place