Status:
COMPLETED
A Personalized Diet Study to Reduce Glycemic Exposure
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
American Heart Association
Weizmann Institute of Science
Conditions:
Pre-diabetes
Overweight and Obesity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese pr...
Eligibility Criteria
Inclusion
- Healthy overweight or obese prediabetic (HbA1c \<8.0%)
- BMI ≥27 kg/m2
- Oral medications with metformin, sulfonylureas, DPP4 inhibitors
- Posses smartphone or use study loaner smartphone
Exclusion
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
- unwilling to accept randomization assignment
- women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study
- institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet)
- unwilling to delay bariatric surgery for the next 12 months
- diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D)
- chronically active inflammatory or neoplastic disease in the past 3 years
- diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease)
- diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study
- taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring \[CGM\] device)
- taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study
- managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin)
- prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months
- +/- 5% weight change within last month at screening
- a eGFR \<60 mL/min/1.73m2
- younger than 18 or older than 80 years old.
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT03336411
Start Date
December 12 2017
End Date
October 27 2021
Last Update
March 10 2022
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016