Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB (FGB)

The Washington University

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Low-calorie diet; Procedure: Roux-en-Y gastric bypass surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03091725

201612107

Details and patient eligibility

About

The purpose of this study is to compare the metabolic responses to low-carbohydrate and standard-carbohydrate meals in African Americans and non-Hispanic White adults with obesity and the effect of weight loss induced by low-calorie diet (LCD) or Roux-en-Y gastric bypass (RYGB) on the metabolic responses to low-carbohydrate and standard meals. Participants will consume: 1) a standard-carbohydrate meal (~49 g glucose) and 2) a low-carbohydrate (~3.4 g glucose) meal on separate study visits performed in a randomized order. We will evaluate the meals' effect before and after ~16-18% weight loss on postprandial i) insulin kinetics, ii) glucose kinetics iii) β-cell function; iv) plasma triglyceride and non-esterified fatty acid concentrations; v) plasma hormone concentrations; vi) plasma cytokine concentrations; vi) plasma metabolomics; and vii) adipose tissue transcriptomics.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Surgery Group (RYGB):

• Males and Females
• Scheduled for RYGB surgery
• Body Mass Index 35-60 kg/m²
• Without Type 2 Diabetes (T2D)

LCD group:

• Males and Females
• Body Mass Index 35-60 kg/m²
• Without Type 2 Diabetes (T2D)

Exclusion criteria

• Regular use of tobacco products
• Previous intestinal resection
• Pregnant or breastfeeding
• Evidence of significant organ system dysfunction or disease other than obesity and T2D
• Use of any medication that might, in the opinion of the investigator, affect metabolic function
• Exercise ≥90 minutes per week
• Use or past use of hormone replacement therapy within the past 6 months

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

RYGB group

Experimental group

Description:

Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after \~16-18% weight-loss

Treatment:

Procedure: Roux-en-Y gastric bypass surgery

LCD Group

Active Comparator group

Description:

Subjects in this group will participate in a low-calorie diet intervention to achieve \~16-18% weight loss.

Treatment:

Behavioral: Low-calorie diet