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A Dose-Response Study of Human Unacylated Ghrelin on Glycemia during Oral Glucose Tolerance Test in Patients with Type 2 Diabetes Mellitus

A Dose-Response Study of Human Unacylated Ghrelin on Glycemia during Oral Glucose Tolerance Test in Patients with Type 2 Diabetes Mellitus - UAG oGTT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34644
Enrollment
12
Registered
2010-06-21
Start date
2011-05-16
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes insulin sensitivity

Interventions

Overnight infusion of placebo, low and high dose UAG before an oral GTT the following morning

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Female or Male subject of 18 years of age or older; • Documented diagnosis of type 2 diabetes as defined by American Diabetes Association; • Diagnosis of type 2 diabetes for at least 3 months prior to screening; • Metformin monotherapy for at least 3 months prior to screening is allowed • Screening HbA1c between 6.5% and 8.5%; • Body Mass Index between 25 and 35 kg/m2;

Exclusion criteria

Exclusion criteria: • History of or presence of active concomitant conditions or disease that would interfere with the protocol conduct and study assessments, as judged by the investigator; • History or presence of long-term type 2 diabetes complications; • Clinically significant abnormalities in laboratory evaluation at screening, as judged by the investigator; • Use of systemic corticosteroids within 60 days prior to screening; • If female, pregnancy or breast feeding; • Drug or alcohol dependence or abuse; • Participation in a trial of an experimental drug or device within 60 days prior to screening

Design outcomes

Primary

MeasureTime frame
Glucose levels

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)