A Personalized Diet Study to Reduce Glycemic Exposure

NYU Langone Health

Status

Completed

Conditions

Pre-diabetes

Overweight and Obesity

Treatments

Behavioral: mHealth

Behavioral: Personalized mHealth

Study type

Interventional

Funder types

Other

Identifiers

NCT03336411

17-00741

Details and patient eligibility

About

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 prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study.

Enrollment

269 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.