Study of the Food Order Behavioral Intervention in Prediabetes

Completed · Not applicable

Conditions studied: Pre Diabetes, Obesity

In brief

Investigators have previously shown that eating carbohydrates after protein or vegetables resulted in reduced glucose and insulin excursions over 180 min in patients with T2DM and in individuals with prediabetes as well. This is an open label, randomized controlled pilot study to assess the efficacy of carbohydrate-last food order behavior in reducing the risk of progression to type 2 diabetes (T2DM).

Key facts

Study ID

NCT03896360

Run by

Weill Medical College of Cornell University

People needed

79

Starts

2019-02-28

Expected to finish

2022-01-21

Last updated by the study team

2022-02-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects who are 21 years of age or older
• BMI 25-40 kg/m2
• Pre-diabetes defined by an HbA1c of 5.7-6.4%
• Weight stable (< 5% body weight change over preceding 6 months)
• Provide valid informed consent

You may not qualify if…

• Previous diagnosis of T2DM or Hb1A1c greater than or equal to 6.5% or fasting glucose > 125mg/dl on screening or 2 hour glucose greater than or equal to 200 mg/dl on OGTT
• Patients who are on any oral/ injectable medications used to treat diabetes including metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT2 inhibitors, glitazones and insulin
• Patients on over the counter or approved weight loss medications
• Pregnant or lactating females
• Previous bariatric surgery
• Psychotropic and/or other medications known to significantly impact weight unless on stable dose for 6 months
• eGFR < 45ml/min
• Significant hepatic, cardiac, gastrointestinal, neurologic or other medical illness that would preclude participation in the study
• Untreated hypothyroidism or other endocrine disorders
• Non-English speaking patients
• Any patient deemed unsuitable in the investigator's opinion

Where it is running

• Comprehensive Weight Control Center — New York, New York, United States

Full record on ClinicalTrials.gov

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