Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women

NCT00145392 | Completed

• 1 other identifier: 005
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we will clarify the degree of insulin resistance and characterise muscle glucose metabolism and gene expression in a group of overweight healthy women. The study will clarify how overweight influences body glucose metabolism and thereby in the long-run increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some overweight women develop hormone disorders and diabetes while others remain healthy. The study is essential as many patients suffer from diseases aggravated by overweight. In addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to the disease if the patient gains weight. It is therefore important that weight-matched control subjects are included in projects with overweight patients. This clinical trial includes 10 overweight women with regular hormones and normal level of male sex hormone. The patients included must be healthy, take no medications influencing the study results. The subjects must take no contraceptive pills or receive any other hormone treatment. In connection with the investigation, the following will be carried out on all patients: clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone scan. The purpose of the study is to gain more knowledge of how overweight influences women's risk of developing hormone diseases and diabetes.

Conditions

Obesity; Type 2 Diabetes; Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; growth hormone; insulin resistance; overweight; glucose metabolism

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menses, i.e. cyclus length 25-34 days
• Premenopausal
• Ferrimann-Gallway score \< 2
• BMI \> 27 kg/m2
• normal total testosterone value \< 3.5 nmol/l

You may not qualify if:

• Age \<18 years
• Contraceptive pills within the past 3 months
• Postmenopausal (increased FSH)
• Diabetes mellitus
• Endocrine or other disease requiring treatment
• Eating disorder or other psychiatric history
• Drug use known to influence parameters investigated in this trial
• Pregnancy

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Polycystic Ovary Syndrome; Insulin Resistance; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Hyperinsulinism

Study Officials

• Dorte Glintborg, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2002
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 24, 2008

Record last verified: 2008-06

Locations

DK (1)