NAD supplementation for improving kidney health in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2a trial is a randomized, double-blind, placebo-controlled study designed to evaluate the effects of NMN (β-Nicotinamide Mononucleotide) on diabetic kidney disease (DKD) in older adults with type 2 diabetes. Participants will be randomly assigned to receive either 1000 mg of NMN or a placebo twice daily, with the primary outcome being the change in urine albumin to creatinine ratio (UACR). The study aims to determine if NMN can significantly reduce UACR compared to placebo, indicating improved kidney function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Shalender Bhasin, MD — Brigham and Women's Hospital
• Study coordinator: Shalender Bhasin, MD
• Email: sbhasin@bwh.harvard.edu
• Phone: 6175259150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.