RECRUITING

NAD Augmentation in Diabetes Kidney Disease

Conditions

Type2diabetes Diabetic Kidney Disease diabetes type 2 diabetes kidney disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial

Quick Facts

Study Start:2023-04-13

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05759468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Shalender Bhasin, MD

CONTACT

6175259150

sbhasin@bwh.harvard.edu

Nancy Latham, PhD

CONTACT

6179999195

nklatham@bwh.harvard.edu

Principal Investigator

Shalender Bhasin, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Shalender Bhasin, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2023-04-13

Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

diabetes
type 2 diabetes
kidney disease

Additional Relevant MeSH Terms

Type2diabetes
Diabetic Kidney Disease