Jejunal Ketogenesis and Type 2 Diabetes

NCT05767177 | Completed

• 1 other identifier: Ketogen05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2; Intestines; Incretins

Outcome Measures

Primary Outcomes (1)

• Glucemia following a Mixed Meal Test:

  The study participant arrives fasted and a venous catheter is placed in one arm for blood sampling. The research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal) and the p-glucose (mM) is checked at 120 min. The glucemia after the test meal will be compared in high-carbohydrate diet and high-fad diet (paired samples).

  On day 12 of the respective diet

Secondary Outcomes (2)

• Enteroscopy: ketogenic activity in the small intestine

  On day 14 of the respective diet

• Enteroscopy: mucosal glucose-transport capacity

  On day 14 of the respective diet

Other Outcomes (1)

• Glucemia, insulinemia and GLPi-emia following the Mixed Meal Test

  On day 12 of the respective diet

Study Arms (1)

High Carbohydrate Diet vs High Fat Diet

EXPERIMENTAL

In the current project, the situation applies to individuals with obesity (body mass index (BMI) 35 to 45 kg/m2). In one case the diet is of the type "high-carbohydrate diet" and in the other case "high-fat diet". The idea is that the research subjects should subsist on these diets for the respective 14 days. The energy content of the diet periods must be the same and correspond to the participants' daily needs. Each participant is drawn to one diet for 2 weeks. After a break of at least 3 weeks, the second diet is taken for 2 weeks.

Other: Glucemia following Mixed Meal Test; Other: Enteroscopy - mucosal ketogenic activity as well as glucose transport

Interventions

Glucemia following Mixed Meal Test OTHER

On day 12 of each diet, a venous catheter is placed in one arm for blood sampling and the research person must answer questions about any gastrointestinal complaints in connection with the current diet. At approximately 09:00, the research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal). Venous blood samples are taken before and 15, 30, 45, 60, 90 and 120 minutes after the meal.

High Carbohydrate Diet vs High Fat Diet

Enteroscopy - mucosal ketogenic activity as well as glucose transport OTHER

On day 14 of each diet period, an enteroscopy is performed. This step is performed to obtain samples (biopsy) of the mucosa of the small intestine (duodenum and jejunum) and is performed at the Gastro-endoscopic departments SU-Sahlgrenska, or SU-Eastern hospital. Endoscopy is experienced by some individuals as unpleasant, which is why local anesthesia and sometimes sedation (midazolam + pethidine or rapifen) can be offered according to standard routine in the endoscopy department.

High Carbohydrate Diet vs High Fat Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 35 to 45 kg/m2

You may not qualify if:

• Insulin-treated diabetes
• Sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.)
• Diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment
• Continuous NSAID use
• Preferably otherwise medication-free (exceptions can be made)
• Not operated on in the abdomen (appendectomy excluded)
• Previously known organic gastrointestinal disease, except for gastroesophageal reflux disease (GERD)
• Smokers
• Pregnancy and breastfeeding
• History of drug abuse or other circumstances deemed to jeopardize the patient's ability to participate in the research project

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Dept of Surgery, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lars Fändriks, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 14, 2023
• Study Start: June 1, 2023
• Primary Completion: April 19, 2025
• Study Completion: April 22, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)