Effect of Exercise on Insulin Resistance

NCT01941277 | Terminated

• 1 other identifier: BSTE-0902
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes). It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

• A decrease in Insulin Resistance (IR) as measured by a change in IR.

  change between baseline and 6 weeks

Study Arms (2)

Intensive Exercise Group

EXPERIMENTAL

Behavioral

Behavioral: Intensive Exercise Group

Current Recommendations Exercise Group

EXPERIMENTAL

Behavioral

Behavioral: Current Recommendations Exercise Group

Interventions

Current Recommendations Exercise Group BEHAVIORAL

Current Recommendations Exercise Group

Intensive Exercise Group BEHAVIORAL

Intensive Exercise Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years.
• Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment);
• Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ≤ 125 mg/dL (6.0-6.9 mmol/L)
• HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
• hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
• No clinically significant adverse exercise response during the maximal graded exercise test

You may not qualify if:

• Weight loss diet program or weight change (\>10%) within the past 6 months
• Daily physical activity of \>10,000 steps per day (as measured during the interval between visits 1 and 2)
• Participates in deliberate structured exercise
• Pregnant or intending to become pregnant
• Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
• Unwillingness to participate in all study procedures
• Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
• BMI greater than 40 kg/m2
• Concurrent participation in another lifestyle modification trial
• Diagnosis of diabetes based on any one of the following criteria:
• Fasting plasma or whole blood glucose ≥ 126 mg/dL (7 mmol/L)
• HbA1c of \>6.5% (\>47 mmol/mol)
• hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an OGTT
• Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:
• Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months

Sponsors & Collaborators

• Alere San Diego: lead

Study Sites (2)

Manchester University

Manchester, M23 9QZ, United Kingdom

Location

Move Lab

Newcastle upon Tyne, NE1 7RU, United Kingdom

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rick San George, PhD

  Alere San Diego

  STUDY DIRECTOR

• Michael Trenell, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

GB (2)