P4 Approach in Diabetes Type 2

NCT02196350 | Completed

• 1 other identifier: P9607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief Summary

The study aims to assess the impact of the P4 approach on established markers of glucose metabolism in type 2 diabetics. Secondary objectives are examination of the changes in physical characteristics, quality of life and the indices for beta cell function, hepatic insulin resistance and muscle insulin resistance .

Conditions

Type 2 Diabetes

Keywords

personalized treatment; prevention; improved diagnosis

Outcome Measures

Primary Outcomes (4)

• Change in HbA1c levels

  Changes in primary outcome measures will be determined by using a mixed model

  In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months

• Change in 2h glucose levels

  2h glucose will be measured after Oral Glucose Tolerance Test (OGTT). Changes in primary outcome measures will be determined by using a mixed model

  In-study at week 0 (baseline) and 13;

• Change in fasting blood glucose levels

  After 8 hour fasting. Changes in primary outcome measures will be determined by using a mixed model.

  In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months

• percentage of participants that reach normoglycemia

  normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L

  end of study (after 13 weeks)

Secondary Outcomes (10)

• body weight

  screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months

• blood pressure

  screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months

• waist circumference

  screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months

• body fat percentage

  screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months

• change indices for muscle insulin resistance

  screening; in-study at week 0 and 13;

Study Arms (4)

Intervention A: Diet

EXPERIMENTAL

Intervention A: One week of very low calorie diet, 12 weeks of low calorie diet; exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen).

Behavioral: Intervention A: Diet

Intervention B: Exercise

EXPERIMENTAL

Intervention B: Combination of strength and endurance training, 3 x per week 60 minutes according to the Exercise Program Diabetes (Beweegprogramma Diabetes). Healthy isocaloric diet.

Behavioral: Intervention B: Exercise

Intervention C: Diet and Exercise

EXPERIMENTAL

Intervention C: one week very low calorie diet, followed by 12 weeks healthy isocaloric diet. One week exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen) followed by 12 weeks strength and endurance training (3 x per week 60 minutes) according to the Exercise Program Diabetes (Beweegprogramma Diabetes)

Behavioral: Intervention C: Diet and Exercise

Control - Historical data

NO INTERVENTION

Historical data from the GPs Information System from 60 newly diagnosed type 2 diabetes patients in the last five years will be used as control.

Interventions

Intervention A: Diet BEHAVIORAL

subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice

Also known as: very low calorie diet based on Modifast meal replacers.

Intervention A: Diet

Intervention B: Exercise BEHAVIORAL

subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.

Intervention B: Exercise

Intervention C: Diet and Exercise BEHAVIORAL

subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.

Also known as: very low calorie diet based on Modifast meal replacers.

Intervention C: Diet and Exercise

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as assessed by the
• health and lifestyle questionnaire, (P9607 F02; in Dutch)
• physical examination
• results of the pre-study laboratory tests
• Age 30-80 years
• Stable BMI 25-35 kg/m2
• Diagnosis diabetes type 2 based upon:
• Fasting glucose \>6.9 mmol/l on two different days or one measurement of non-fasting glucose \>11.0 mmol/l in combination with symptoms of hyperglycemia
• Duration of diabetes maximally 1 year
• Informed consent signed;
• Willing to comply with the study procedures during the study;
• Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);
• Voluntary participation
• Physically able to perform training activities
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.

You may not qualify if:

• Use of insulin, corticosteroids (systemic), or beta-blockers in past month
• Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
• Slow onset type 1 diabetes
• Use of oral diabetes medication in past year
• (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.
• Hypertension: systolic blood pressure \>160 mmHg, diastolic blood pressure \>90 mmHg
• Kidney problems based upon proteinuria and creatinine \>150 mmol/l
• Insufficient beta cell function based on Disposition index \< 1.5 as determined during the OGTT in study on day 01\*
• Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))
• Alcohol consumption \> 21 (women) - 28 (men) units/week
• Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
• Recent blood donation (\<1 month prior to the start of the study)
• Not willing to give up blood donation during the study
• Personnel of TNO and their partner
• Not having a general practitioner

Sponsors & Collaborators

• W.J. Pasman: lead

Study Sites (9)

Huisartsenpraktijk Lommelaars

Hillegom, South Holland, 2181 EK, Netherlands

Location

Huisartspraktijk C.C. Dekker

Hillegom, South Holland, 2181 EN, Netherlands

Location

Huisartspraktijk Tubbergen

Hillegom, South Holland, 2181 EN, Netherlands

Location

Huisartsenpraktijk Sixlaan 9

Hillegom, South Holland, 2182 AA, Netherlands

Location

Huisartsenpraktijk J.G. van Dusseldorp

Hillegom, South Holland, 2182 CA, Netherlands

Location

Huisartsenpraktijk van der Kaaden

Hillegom, South Holland, 2182 GP, Netherlands

Location

Huisartsenpraktijk Elsbroek

Hillegom, South Holland, 2182 LN, Netherlands

Location

Huisartsenpraktijk Mulders

Hillegom, South Holland, 2182 VT, Netherlands

Location

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, 3704 HE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wilrike Pasman, PhD

  Netherlands Organisation for Applied Scientific Research (TNO)

  PRINCIPAL INVESTIGATOR

• Peter van Dijken, Dr.

  Netherlands Organisation for Applied Scientific Research (TNO)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

NL (9)