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Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

Primary Purpose

Type 2 Diabetes Mellitus, Hypogonadism

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Testosterone

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male gender age 50-70
Bioavailable testosterone < 7,3 nmol/L
Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%,
Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times,
Abnormal routine blood samples,
Severe hypertension,
Significant EKG-changes,
Wish of parenthood,
Active mental illness,
former or present abuse,
Severe illness of heart-, lung- or kidney,
Primary or secondary hypogonadism.

Sites / Locations

Department of Endocrinology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Testim

Placebo

Arm Description

Placebo for 24 weeks

Outcomes

Primary Outcome Measures

Lean body mass

Accessed by DXA scanning

Secondary Outcome Measures

Insulin sensitivity

Euglycemic hyperinsulinaemic clamp

Regional body composition and liver fat

DXA- and MR-scans and spect

Glucose and lipid oxidation

Indirect calorimetry

Myostatin and satellite cells

Muscle biopsy

Inflammation

Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.

Physical activity

Questionaires

Quality of life

Questionaires

Sexual function

Questionaires

Full Information

NCT ID

NCT01560546

First Posted

March 20, 2012

Last Updated

November 13, 2013

Sponsor

Marianne Andersen

Collaborators

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01560546

Brief Title

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

Official Title

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marianne Andersen

Collaborators

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM. Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance. Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.

Detailed Description

Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Hypogonadism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Testim

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Testosterone

Other Intervention Name(s)

Testim

Intervention Description

50 mg/dose/day for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo on the skin for 24 weeks

Primary Outcome Measure Information:

Title

Lean body mass

Description

Accessed by DXA scanning

Time Frame

approximately three years

Secondary Outcome Measure Information:

Title

Insulin sensitivity

Description

Euglycemic hyperinsulinaemic clamp

Time Frame

three years

Title

Regional body composition and liver fat

Description

DXA- and MR-scans and spect

Time Frame

three years

Title

Glucose and lipid oxidation

Description

Indirect calorimetry

Time Frame

three years

Title

Myostatin and satellite cells

Description

Muscle biopsy

Time Frame

8 years

Title

Inflammation

Description

Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.

Time Frame

8 years

Title

Physical activity

Description

Questionaires

Time Frame

three years

Title

Quality of life

Description

Questionaires

Time Frame

three years

Title

Sexual function

Description

Questionaires

Time Frame

Three years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male gender age 50-70 Bioavailable testosterone < 7,3 nmol/L Metformin treatment of T2DM for 3 months or more Exclusion Criteria: HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%, Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times, Abnormal routine blood samples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, former or present abuse, Severe illness of heart-, lung- or kidney, Primary or secondary hypogonadism.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Andersen, MD, ph.d.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28168203

Citation

Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.

Results Reference

derived

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Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

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