Effects of combined administration of L-tryptophan and lauric acid on gut functions, and blood glucose control in humans with type 2 diabetes

Not Applicable

Recruiting

• Conditions: Type 2 diabetes; Obesity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12623000778684
• Lead Sponsor: Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Male participants with type 2 diabetes mellitus (T2DM), (aged 18-75 years BMI: 28-38 kg/m2), will be included in the study. T2DM diagnosis will be based on WHO criteria. HbA1c will be >=6.5 - <=7.9% at screening. Blood glucose medications will be required to be withheld for 48 hours prior to each study day. All participants will be required to be weight-stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

Exclusion Criteria

Significant GI symptoms, or history of GI disease or surgery
Current gallbladder or pancreatic disease
Cardiovascular or respiratory diseases
Any other illnesses (except type 2 diabetes) as assessed by the investigator (including chronic illnesses not explicitly listed above)
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, bodyweight or appetite (e.g. domperidone, cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
Lactose intolerance/other food allergy(ies)
Individuals with low ferritin levels (<30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
High performance athletes
Current intake of > 2 standard drinks on > 5 days per week (>140g/week)
Current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)
Current use of recreational drugs, e.g. marijuana
Current intake of any illicit substance
Vegetarians
Inability to tolerate nasoduodenal tube
Inability to comprehend study protocol
HbA1c <6% or >7.9%
Estimated glomerular filtration rate <45 ml/min
Any patient whose medication cannot be withheld for 48 hours for medical reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified