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Completed

NCT Number: NCT01593215

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skanes Universitetssjukhus

Malmö, Skåne County, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Yohimbine

Drug

Yohimbine capsule

Primary outcomes

  1. Insulin Secretion

    Time frame: 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 outcomes

  1. Glucose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anders Rosengren, MD PhD

Other

Collaborators

  • Lund University
  • Region Skane

Registry information

Acronym: YOH1

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 8, 2012
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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