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| Name | Class |
|---|---|
| NeuroMetrix, Inc. | INDUSTRY |
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The purpose of this study is to find out the impact of improving diabetes control through weight reduction and lifestyle changes on a common diabetes complication called peripheral neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Treatment (Why WAIT) | Experimental | Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications. |
|
| Control Group | No Intervention | Matched control group will be recruited from obese patients with diabetes followed at Joslin Clinic. This group will receive the routine standard diabetes care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Achievement and Intensive Treatment (Why WAIT) | Other | Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sural nerve conduction velocity | The NCstat DPNCheck device(an FDA approved device) measures the sural nerve conduction velocity. The sural nerve conduction velocity is the gold standard in assessing diabetic peripheral neuropathy. | Baseline, at 3 months, at 6 months, at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sural Nerve Amplitude potential | The NCstat DPNCheck device(an FDA approved device) measures the sural nerve Amplitude potential. The sural nerve is the gold standard in assessing diabetic peripheral neuropathy. | Baseline, at 3 months, at 6 months, at 12 months |
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Inclusion Criteria:
Inclusion of Intervention group:
Inclusion of controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama M Hamdy, MD., PhD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |