NAD Augmentation in Diabetes Kidney Disease
NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether NMN helps people with diabetes-related kidney disease by lowering protein in their urine. Participants will be assigned by chance to take either 1,000 mg of NMN or a placebo (a pill with no active drug) twice a day.
A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 30 or older and either a man or a woman who has gone through menopause. Women must not be pregnant or plan pregnancy in the next 6 months.
- Have type 1 or type 2 diabetes, shown by diabetes history and prescribed medicine, medical records and medicine use, or blood sugar tests.
- Have at least 2 morning urine protein tests (UACR) averaging 100 mg/g or higher, with each at least 60 mg/g. At least one must be done at screening; a result from the past 3 months may also count.
- If you have type 2 diabetes and UACR above 300 mg/g, take an ACE inhibitor, ARB, or SGLT2 inhibitor—types of blood pressure or diabetes medicines.
- Have an eGFR (a measure of kidney function) above 25.
- Have an A1c (average blood sugar level) below 10%.
- Speak English, Spanish, or Haitian Creole.
- Be willing and able to give written consent to join.
Who can't join
- Have a fasting morning urine protein test (UACR) above 5,000 mg/g, kidney function (eGFR) below 25, liver tests (AST or ALT) above 3 times normal, or a red blood cell share (hematocrit) below 34% or above 50%.
- Had a major heart or blood vessel event in the past 3 months.
- Joined another study testing a drug or biological treatment within the past 3 months or 5 drug half-lives, whichever is shorter. A half-life is the time it takes the body to clear half a drug.
- Currently have an alcohol or drug use disorder or dependence.
- Have major depression, bipolar disorder, schizophrenia, or current psychotic symptoms or behavior problems that could interfere with study tasks.
- Had a sudden illness, including COVID-19, needing a hospital stay in the past 3 months, or any sudden illness in the past month.
- Have had anaphylaxis (a severe allergic reaction) to a form of vitamin B3, or have a BMI (a weight-to-height measure) above 42.5.
- Have a confirmed diagnosis of type 3 diabetes or gestational diabetes (diabetes during pregnancy).
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH \> 20 U/L), 30 years or older 2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following: 1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication. 2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record. 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL 3. Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit. a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable. 4. If type 2 diabetic and UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor. 5. eGFR \> 25 mL/ min / 1.73 m2 6. Hemoglobin A1c \<10% 7. Able to speak English or Spanish or Haitian Creole 8. Willing and able to provide written informed consent 9. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months. Exclusion criteria: 1. Fasting morning UACR \> 5,000 mg/ g creatinine 2. Other laboratory abnormalities: 1. Has AST or ALT \> 3 times the upper limit of normal 2. eGFR \< 25 mL/ min / 1.73 m2 3. Hematocrit \< 0.34 or \> 0.50 L/L 3. A major adverse cardiovascular event in preceding 3 months 4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter 5. Current alcohol or substance use disorder or dependence (DSM 5 criteria). 6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures. 7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month. 8. Has a history of anaphylaxis from vitamin B3 derivatives 9. BMI \> 42.5 kg/ m2 10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.
Study sites (1)
MA
- Brigham and Women's Hospital · Boston, MA 02115Nancy K Latham, PhD · Study contact · 6179999195 · nklatham@bwh.harvard.eduShalender Bhasin, MB BS · Principal investigatorNancy Latham, PhD · Sub-investigatorMore trials in Boston