Diabetic NeuropathiesNMFNCT05145452
n-3 Polyunsaturated Fatty Acids to Prevent and Treat Diabetic Neuropathy
A study testing Fish-oil derived n-3 polyunsaturated fatty acids in people with Diabetic Neuropathies, run by University of Missouri-Columbia at 2 sites in United States.
Trial summary
Sensorimotor neuropathy (SMN) and cardiovascular autonomic neuropathy (CAN) are the most common complications of type 2 diabetes (T2D). SMN affects ~30% of people with T2D and CAN ~20%. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Fish-oil derived n-3 polyunsaturated fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2021to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: ≥55 and ≤80 years
- BMI: ≥25.0 and ≤39.9 kg/m2;
- normal plasma glucose (fasting plasma glucose <100 mg/dl and plasma glucose 2 h after a 75 g glucose challenge <140 mg/dl) for the control group and impaired fasting plasma glucose (≥100 mg/dl) or impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) or both for the intervention groups
Who cannot join
- age: <55 and >80 years
- BMI: <25.0 and >39.9 kg/m2
- fasting plasma glucose ≥100 mg/dl or plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl for the control group and normal plasma glucose (fasting plasma glucose <100 mg/dl, plasma glucose at 2 h after 75 g glucose ingestion <140 mg/dl) for the intervention groups
- treatment for T2D, except for metformin
- regular structured high-intensity exercise >150 min total per week
- significant neurological or other organ system dysfunction (e.g., progressive neuromuscular disease, unstable angina, vasculitis, certain cardiopulmonary diseases, cancer that has been in remission for <5 years, dementia, allergies to the dietary supplement) or significant ambulatory impairments (e.g., limb amputations, being wheelchair-bound)
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- use of certain medications that are incompatible with the study procedures (e.g., certain anticoagulants) or could confound the study outcomes (e.g., anabolic steroids, metronidazole, etc) alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking >20 cigarettes per week
- regular consumption of fish oil supplements or >2 servings of fatty fish per week
- x) prisoners, and persons who are unable to grant voluntary informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University School of Medicine
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
Sensorimotor neuropathy (SMN) and cardiovascular autonomic neuropathy (CAN) are the most common complications of type 2 diabetes (T2D). SMN affects ~30% of people with T2D and CAN ~20%. SMN causes pain, impairs and limits physical activity, and increases the risk for physical disability, complications (such as foot ulcerations), and premature mortality. Moreover, both motor and sensory nerve function are important regulators of muscle function; impaired myofiber innervation causes myofiber loss, muscle fat infiltration, and increases the risk of age-associated sarcopenia and falls. CAN often goes unrecognized because it presents with non-specific symptoms, such as resting tachycardia and fixed heart rate, exercise intolerance, and orthostatic hypotension. However, CAN is a serious problem because it increases the risk for cardiovascular events and mortality several-fold. Both SMN and CAN have long been considered a consequence of T2D, but it is now becoming clear that they precede the diagnosis of T2D and are already detectable in people with prediabetes, especially those with impaired glucose tolerance. Treatments for both SMN and CAN focus on symptom management because there are no effective therapeutics that target the underlying neuropathy. The results from studies conducted in animal models suggest fish oil-derived n-3 polyunsaturated fatty acids (n-3 PUFA) may have therapeutic effects for people with SMN and CAN. The purpose of this proposal is to conduct a randomized controlled trial to test the hypothesis that dietary supplementation with fish oil-derived n-3 PUFA improves sensorimotor and cardiovascular autonomic functions in people with impaired glucose tolerance. Forty 55-80 year old men and women with impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) and evidence of SMN (assessed as epidermal nerve fiber density) will be randomized to either receive fish oil-derived n-3 PUFA (4.2 g per day; n=20) or placebo (n=20) for six months. Sensorimotor and cardiovascular autonomic function will be evaluated after three and 6 months of the interventions.
- Conditions
- Diabetic Neuropathies
- Being tested
- Fish-oil derived n-3 polyunsaturated fatty acids
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish-oil derived n-3 polyunsaturated fatty acidsDietary supplement
4.2 g/d (7 pills with 600 mg each)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects randomized to n-3 PUFA will receive a total of 4.2 g/d of fish oil. Receives: Dietary Supplement: Fish-oil derived n-3 polyunsaturated fatty acids |
| Placebo Group | Placebo comparator | Subjects randomized to placebo will receive 4.2 g/d sunflower oil. Receives: Dietary Supplement: Fish-oil derived n-3 polyunsaturated fatty acids |
| Control group | No intervention | Subjects assigned to the control group will be tested once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensorimotor function
Nerve conduction velocity
Measured: Change from baseline to 6 months
Cardiovascular autonomic function
Heart rate variability
Measured: Change from baseline to 6 months
Muscle endurance
Decline in torque during repeat muscle contraction
Measured: Change from baseline to 6 months
Secondary outcomes (6)
Glucose tolerance
Glucose tolerance (plasma glucose concentration during a 75 gram glucose tolerance test)
Measured: Change from baseline to 6 months
Insulin sensitivity
Oral insulin sensitivity index
Measured: Change from baseline to 6 months
Beta cell function
Insulin secretion rate
Measured: Change from baseline to 6 months
Plasma triglyceride concentration
Plasma triglyceride concentration
Measured: Change from baseline to 6 months
Muscle strength
Muscle strength
Measured: Change from baseline to 6 months
Physical performance
Physical performance test
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start14 Jan 2021
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Why it stopped: Due to the COVID-19 pandemic, enrollment was interrupted. The intervention pills expired and unable to obtain more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145452
- Sponsor's protocol ID
- 2097478
- Acronym
- NMF
- Status last verified
- Feb 2024
- First submitted
- 9 Jul 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- n-3 Polyunsaturated Fatty Acids to Prevent and Treat Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05145452
- Acronym / sponsor ID
- NMF / 2097478
- Conditions
- Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic, enrollment was interrupted. The intervention pills expired and unable to obtain more.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sensorimotor neuropathy (SMN) and cardiovascular autonomic neuropathy (CAN) are the most common complications of type 2 diabetes (T2D). SMN affects ~30% of people with T2D and CAN ~20%. SMN causes pain, impairs and limits physical activity, and increases the risk for physical disability, complications (such as foot ulcerations), and premature mortality. Moreover, both motor and sensory nerve function are important regulators of muscle function; impaired myofiber innervation causes myofiber loss, muscle fat infiltration, and increases the risk of age-associated sarcopenia and falls. CAN often goes unrecognized because it presents with non-specific symptoms, such as resting tachycardia and fixed heart rate, exercise intolerance, and orthostatic hypotension. However, CAN is a serious problem because it increases the risk for cardiovascular events and mortality several-fold. Both SMN and CAN have long been considered a consequence of T2D, but it is now becoming clear that they precede the diagnosis of T2D and are already detectable in people with prediabetes, especially those with impaired glucose tolerance. Treatments for both SMN and CAN focus on symptom management because there are no effective therapeutics that target the underlying neuropathy. The results from studies conducted in animal models suggest fish oil-derived n-3 polyunsaturated fatty acids (n-3 PUFA) may have therapeutic effects for people with SMN and CAN. The purpose of this proposal is to conduct a randomized controlled trial to test the hypothesis that dietary supplementation with fish oil-derived n-3 PUFA improves sensorimotor and cardiovascular autonomic functions in people with impaired glucose tolerance. Forty 55-80 year old men and women with impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) and evidence of SMN (assessed as epidermal nerve fiber density) will be randomized to either receive fish oil-derived n-3 PUFA (4.2 g per day; n=20) or placebo (n=20) for six months. Sensorimotor and cardiovascular autonomic function will be evaluated after three and 6 months of the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Fish-oil derived n-3 polyunsaturated fatty acidsSubjects randomized to n-3 PUFA will receive a total of 4.2 g/d of fish oil. |
| Placebo Group | Placebo comparator | Dietary Supplement: Fish-oil derived n-3 polyunsaturated fatty acidsSubjects randomized to placebo will receive 4.2 g/d sunflower oil. |
| Control group | No intervention | –Subjects assigned to the control group will be tested once |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: ≥55 and ≤80 years
- BMI: ≥25.0 and ≤39.9 kg/m2;
- normal plasma glucose (fasting plasma glucose <100 mg/dl and plasma glucose 2 h after a 75 g glucose challenge <140 mg/dl) for the control group and impaired fasting plasma glucose (≥100 mg/dl) or impaired glucose tolerance (plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl) or both for the intervention groups
Key exclusion criteria (9 listed)
- age: <55 and >80 years
- BMI: <25.0 and >39.9 kg/m2
- fasting plasma glucose ≥100 mg/dl or plasma glucose 2 h after a 75 g glucose challenge ≥140 mg/dl for the control group and normal plasma glucose (fasting plasma glucose <100 mg/dl, plasma glucose at 2 h after 75 g glucose ingestion <140 mg/dl) for the intervention groups
- treatment for T2D, except for metformin
- regular structured high-intensity exercise >150 min total per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish-oil derived n-3 polyunsaturated fatty acids4.2 g/d (7 pills with 600 mg each) | Dietary supplement | Intervention Group, Placebo Group |
Primary outcome
Sensorimotor function
Time frame: Change from baseline to 6 months
Nerve conduction velocity
Cardiovascular autonomic function
Time frame: Change from baseline to 6 months
Heart rate variability
Muscle endurance
Time frame: Change from baseline to 6 months
Decline in torque during repeat muscle contraction
6 secondary outcomes
Glucose tolerance
Time frame: Change from baseline to 6 months
Insulin sensitivity
Time frame: Change from baseline to 6 months
Beta cell function
Time frame: Change from baseline to 6 months
Plasma triglyceride concentration
Time frame: Change from baseline to 6 months
Muscle strength
Time frame: Change from baseline to 6 months
Physical performance
Time frame: Change from baseline to 6 months
Results and safety
The study was stopped early (reason given: Due to the COVID-19 pandemic, enrollment was interrupted. The intervention pills expired and unable to obtain more.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Mittendorfer principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish-oil derived n-3 polyunsaturated fatty acids in people with Diabetic Neuropathies, run by University of Missouri-Columbia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the COVID-19 pandemic, enrollment was interrupted. The intervention pills expired and unable to obtain more.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensorimotor function (time frame: Change from baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.