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A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes

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ClinicalTrials.gov Identifier: NCT03896360
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes [ Time Frame: 16 weeks ]
Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes as measured by the proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes
Official Title  ICMJE A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes
Brief Summary 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).
Detailed Description Intensive diet and lifestyle modifications have been shown to reduce the risk of progression to T2DM in several randomized controlled trials. Key components of standard nutritional counseling include reducing calorie intake and glycemic load. Sequential nutrient ingestion is a novel strategy found to attenuate the glycemic effect of a meal. Investigators have previously shown that ingestion of carbohydrates after protein or vegetables results in reduced glucose and insulin excursions over 180 min in patients with T2DM. In addition, investigators also found that levels of the hunger hormone ghrelin were more suppressed at the end of 3 hours after a meal. Furthermore, investigators found that the glycemic effects of food order apply to individuals with prediabetes as well. This study follows previous research on nutrient order and seeks to determine the metabolic effects of this behavioral intervention in the real world. The study will include two randomized groups who are overweight or obese and are diagnosed with prediabetes. The control group will receive standard nutritional counseling at the start of the study and no instructions to change food order behavior. The intervention group will receive regularly scheduled food order counseling over a period of 16 weeks in addition to standard nutritional counseling at baseline. Anthropometric and metabolic parameters, including insulin sensitivity, will be assessed at baseline and at 16 weeks. The primary aim of this study is to determine the proportion of subjects who achieve reversal of prediabetes at study completion and/ or who achieve a 0.2% reduction in hemoglobin A1c. If shown to be effective, this data will inform the design of larger study focused on diabetes prevention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pre Diabetes
  • Obesity
Intervention  ICMJE
  • Behavioral: Food order behavioral intervention plus standard care
    Subjects in the Food order behavioral intervention plus standard care will receive standard counseling by a registered dietitian and additional carbohydrate last food order behavioral counseling by a member of the research team at baseline and Weeks 4, 8 and 12.
  • Behavioral: Standard Care
    Subjects will receive standard counseling by a registered dietitian at the baseline visit. Standard counseling will be similarly reinforced at weeks 4, 8 and 12.
Study Arms  ICMJE
  • Experimental: Food order behavioral intervention plus standard care
    Subjects will receive standard nutrition counseling and additional carbohydrate‐last food order behavioral counseling.
    Intervention: Behavioral: Food order behavioral intervention plus standard care
  • Standard care
    Subjects will receive standard nutrition counseling.
    Intervention: Behavioral: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
85
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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% and 2 hour glucose between 140 - 199 mg/dl on OGTT
  • Weight stable (< 5% body weight change over preceding 6 months)
  • Provide valid informed consent

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896360
Other Study ID Numbers  ICMJE 1807019463
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alpana P Shukla, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP