Do glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) account for the entire incretin effect?

Phase 1

Recruiting

• Conditions: Obesity; Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Diet and Nutrition - Obesity

• Registration Number: ACTRN12619000382178
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-11
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

•Healthy male and females aged from 18 to 40 years, without a family history of T2DM in any 1st degree relative
•Body mass index (BMI) from 19 to 28 kg/m2
•Haemoglobin above the lower limit of the normal range (ie. greater than 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. greater than 30ng/mL for men and greater than 20mg/mL for women).

Exclusion Criteria

•Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin)
•Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
•History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
•Other significant illness, including epilepsy, cardiovascular or respiratory disease
•Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (greater than 2 times upper limit of normal range))
•Donation of blood within the previous 3 months
•Participation in any other research studies within the previous 3 months
•Inability to give informed consent
•Female participants who are pregnant or planning for pregnancy, or are lactating
•Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in the increment in area under the curve (AUC) for insulin to intraduodenal glucose between 4 treatments, above that predicted from the slope of the curve prior to intraduodenal glucose.[t = 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270 min. t = 0 is when intraluminal catheter is correctly positioned and the hyperglycaemic clamp starts and t = 90 min is when intraduodenal glucose starts.]