NAD Augmentation in Diabetes Kidney Disease

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a supplement called NMN to see if it can help improve kidney health in people with type 2 diabetes and diabetic kidney disease. The study is currently recruiting participants who are adults aged 21 and older and have specific health criteria, such as having a certain level of protein in their urine and being on diabetes medication. To participate, individuals should also be able to communicate in English or Spanish and provide written consent.

Participants will be randomly assigned to take either 1000 mg of NMN or a placebo (a pill that doesn't have the active ingredient) twice a day. This means that some people will receive the actual supplement while others will receive a dummy pill. The goal is to see if those taking NMN have a greater improvement in kidney function compared to those taking the placebo. It's important to note that women must not be pregnant or planning to become pregnant during the study. Overall, this trial aims to find out if NMN could be a new way to support kidney health in people with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Has T2DM, as indicated by any of the following:
• • 1. Self-report of diabetes plus the use of a prescribed diabetes medication.
• • 2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.
• • 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
• • 2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days
• • 3. If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB
• • 4. eGFR \> 30 mL/ min / 1.73 m2
• • 5. Hemoglobin A1c \<9%
• • 6. Able to speak English or Spanish
• • 7. Willing and able to provide written informed consent
• • 8. 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 \> 2,000 mg/ g creatinine
• 2. Other laboratory abnormalities:
• • 1. Has AST or ALT \> 3 times the upper limit of normal
• • 2. creatinine \> 2.5 mg/dL
• • 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. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety.
• • 6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years.
• • 7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
• • 8. BMI \> 42.5 kg/ m2