Clinical trial NCT03536364: Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Official title: Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pre-Diabetes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects between 30-65 years of age
2. BMI 25-40kg/m2
3. HbA1c 5.7%-6.4%
4. Willing to comply with study requirements
5. Provide written informed consent

Exclusion Criteria:

1. Known diagnosis of diabetes / taking any medication for treatment of diabetes
2. History of previous bariatric surgery
3. History of chronic liver or renal disease
4. Current treatment with systemic corticosteroids
5. Pregnant women
6. History of allergy to any component of the test meal

Primary outcomes:
measure: Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 30, 60, 90, 120, 150 and 180 mins
measure: Effect of food order on postprandial glucose excursions as measured by post prandial glucose levels (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 30, 60, 90, 120, 150 and 180 mins
measure: Effect of food order on postprandial glucose excursions as measured by incremental area under the curve (iAUC) for glucose ((mg/dl)*180) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 0-180 min
Secondary outcomes:
measure: Effect of food order on postprandial insulin levels (microIU/ml) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 30, 60, 90, 120, 150 and 180 mins
measure: Effect of food order on postprandial insulin incremental area ((microIU/ml)*180min) under the curve in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 0-180 mins
measure: Effect of food order on satiety as measured by a visual analog scale (cm) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
timeFrame: 0,60,120, and 180 mins
Other outcomes:
Locations:
city: New York
country: United States
facility: Comprehensive Weight Control Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Alpana P Shukla, MD
role: PRINCIPAL_INVESTIGATOR
References: