Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Yohimbine

• Registration Number: NCT01593215
• Lead Sponsor: Anders Rosengren, MD PhD

Brief Summary

The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.

Detailed Description

We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2014-10-31
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-07
• Last Update Submitted: 2015-01-07
• Results First Posted: 2015-01-09
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• type 2 diabetes
• informed consent
• age 18-70, for females only postmenopausal

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Exclusion Criteria

• heart disease
• anxiety disorder
• antidiabetic treatment other than metformin
• adrenergic blockers
• ulcus
• allergy to any component in the capsules

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first then yohimbine	Yohimbine	placebo first, then yohimbine
Yohimbine first then placebo	Yohimbine	Yohimbine first then placebo

Primary Outcome Measures

Name	Time	Method
Insulin Secretion	30 minutes after oral glucose	insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.

Secondary Outcome Measures

Name	Time	Method
Glucose	30 minutes after oral glucose	Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.

Trial Locations

Locations (1)

Skanes Universitetssjukhus; 🇸🇪 Malmo, Skane, Sweden