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Lifestyle overhaul may ease diabetic nerve pain

NCT ID NCT01565317

Disease control Sponsor: Joslin Diabetes Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a 12-week intensive lifestyle program focused on weight loss and diabetes control could improve diabetic peripheral neuropathy, a common nerve complication. Fifty adults with diabetes and a BMI between 30 and 45 took part. The program included diet, exercise, and behavioral support. Researchers measured nerve function using a device that checks the sural nerve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lifestyle modification program (diet, exercise, behavioral support)
What this could lead to
If successful, this could show that intensive lifestyle changes and weight loss can help manage or improve diabetic nerve damage.
What could go wrong
This is a small, completed study with only 50 participants. Results may not apply to everyone with diabetes, and lifestyle changes can be hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Start date

Apr 2012

Finished

Jun 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion of Intervention group: 1. Men and Women with established Diabetes. 2. BMI between 30-45 Kg/m2 3. Age: 18-75 years old. 4. Enrolled in the Why WAIT program 5. Diabetes duration of at least 5 years 6. Hb A1C of 6.5% or higher Inclusion of controls: 1. Men and Women with established Diabetes. 2. BMI between 30-45 Kg/m2 3. Age: 18-75 years old. 4. Diabetes duration of at least 5 years 5. Hb A1C of 6.5% or higher Exclusion Criteria: 1. Anatomic changes that preclude the measurement of the nerve conduction: foot deformities, open skin injuries/ulcers, amputations and placement of surgical plates and screws in the ankle and lower leg (tibial) area. 2. Severe diabetic peripheral neuropathy as defined clinically. 3. Severe peripheral vascular disease e.g absent dorsalis pedis pulsation. 4. Recent weight loss/gain (10 pounds) during the past six months. 5. Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies. 6. Individuals with cardiac pacemakers. 7. Women who are Pregnant or who think they might be pregnant.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy diabetic polyneuropathy type 2 diabetes mellitus Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic polyneuropathy Weight loss

Contacts and locations

Locations

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.