Effects of fructose on glucose and lactate excursions during an oral glucose tolerance test

Completed

Conditions: Sugar tolerance
10018424

Registration Number: NL-OMON49169

Lead Sponsor: niversiteit Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

Substudy I:
Healthy men, age 18-75 years, blood Hb >= 8,2 mmol/L.
Healthy women, age 18-75 years, blood Hb >= 7,3 mmol/L, either postmenopausal
women or premenopausal using an oral contraceptive without a *stop week*,

Substudy I protocol amendment for the 10 additional study participants:
Healthy men, age 18-75 years.
Healthy women, age 18-75 years, either postmenopausal women or premenopausal
using an oral contraceptive without a *stop week*,

Substudy II:
a) Genetic diagnosis (i.e. heterozygous carrier) of aldolase B mutation, age
18-75 years.
b) Genetic diagnosis of Maturity-Onset Diabetes of the Young Type 2 (MODY-2),
i.e. carrier of glucokinase mutation, age 18-75 years.
c) Healthy individuals, age 18-75 years.

Exclusion Criteria

• Fasting blood glucose >11 mmol/L;
• Clinical diagnosis of diabetes including type 1 and type 2;
• Use of medications known to interfere with glucose homeostasis (i.e.
corticosteroids);
• Medical conditions that can interfere with the study outcome (i.e.
gastrointestinal disease);
• Cancer, end-stage liver, kidney, cardiac or lung disease;
• Unstable weight for 3 months prior to inclusion (i.e. 5% change in bodyweight
(13));
• Abuse of drugs and/or alcohol;
• Pregnancy;
• Physical stress one month prior to inclusion (i.e. post-surgery, trauma or
infection or extreme psychological stress);
• Periodic hypokalemic paralysis;
• Inability to give inform consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The area under the curve (AUC) for plasma glucose and lactate excursions during<br /><br>an OGTT will be calculated.<br /><br>The glucose and lactate AUCs for the OGTT without fructose will be compared to<br /><br>the glucose and lactate AUCs for the OGTT(s) with fructose. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters:<br /><br>Serum fructose, insulin, triglycerides, urate and beta-hydroxybutyrate levels<br /><br>will be measured at baseline and the end of each OGTT and compared with the<br /><br>OGTT without fructose.<br /><br>Urinary fructose will be measured at the end of each OGTT and compared with the<br /><br>OGTT without fructose.<br /><br>Furthermore, plasma will be stored future analyses.<br /><br><br /><br>Other study parameters include:<br /><br>• Age<br /><br>• Sex<br /><br>• BMI<br /><br>• Waist and hip circumference<br /><br>• Fasting plasma glucose<br /><br>• Fasting serum insulin<br /><br>• Fasting serum lipids (total cholesterol, HDL cholesterol, LDL cholesterol,<br /><br>triglycerides)<br /><br>• Systolic and diastolic blood pressure</p><br>