Energy Balance Following Islet Transplantation

NCT03063229 | Terminated

• 1 other identifier: REC 16/SS0031 R&D: 2016/0118
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Islet transplantation may be appropriate in up to 10% of adults with Type 1 diabetes who suffer repeated episodes of hypoglycaemia with severely impaired awareness of hypoglycaemia (IAH) (1). Our Scotland-wide islet transplant programme performed its first transplant in February 2011 and 30 islet transplants have followed in 18 recipients. Following islet transplantation we have observed improved glycaemic control in all subjects. When metabolic control is improved with exogenous insulin, weight gain is common (2). In our transplant recipients significant reductions in bodyweight and fat mass with no significant reduction in total caloric intake pre- versus post-transplantation has been observed. We hypothesise that energy expenditure is increased post-transplantation leading to weight loss and diminished fat mass. The mechanisms that may be implicated include increased activity energy expenditure, increased resting energy expenditure (REE) and, or, increased post-prandial thermogenesis (PPT= the energy expended after a meal) secondary to increased portal circulation of insulin being partially or fully restored, and diminished circulating systemic insulin concentrations with a decreased propensity for storing fat. The aim of this study is to understand the mechanism of weight loss and body compositional changes by detailed examination of energy intake and energy expenditure in transplant recipients along with control subjects listed for insulin-pump therapy and glucose tolerant controls. These detailed studies are lacking in islet transplantation and are important as they will reveal how physiology is altered post-transplantation, if peripheral hyperinsulinaemia (insulin-pump subjects and pre-transplant subjects) negatively affects energy expenditure and how quantitative measures such as activity energy expenditure, diet and quality-of-life measures such as fear of hypoglycaemia alter post-transplant. This will lead to the improved management of patients with hypoglycaemia and IAH.

Conditions

Type 1 Diabetes

Keywords

Insulin Pump Therapy; Islet Cell Transplant; Energy Expenditure

Outcome Measures

Primary Outcomes (10)

• Body composition

  Using ISAK anthropometry methods. This includes skinfold thicknesses and waist, calf and arm circumference.

  12 Months

• Total energy intake

  including the excess energy intake required in the treatment of hypoglycaemia, using 7 day weighed food diaries,

  12 Months

• The activity component of energy expenditure using accelerometry.

  12 Months

• Resting Energy Expenditure (REE)

  Using Indirect Calorimetry

  12 Months

• Hepatic fat oxidation using Sodium 13C octanoate.

  12 Months

• Liver fat, abdominal subcutaneous and visceral fat using MRI scans.

  12 Months

• BODPOD

  To measure body composition using air displacement plethysmography (Bod Pod).

  12 Months

• Hypoglycaemia scores.

  Fear of Hypoglycaemia Survey, Gold and Clarke Scores.

  12 Months

• Post-Prandial Thermogenesis (PPT)

  Using mixed meal tolerance tests

  12 Months

• Total metabolic Rate (TMR)

  Using Doubly Labelled Water

  12 Months

Study Arms (3)

Islet Transplant Patients

ACTIVE COMPARATOR

Patients with Type 1 Diabetes who are on the waiting list to undergo an islet transplant.

Device: Accelerometer; Other: Anthropomentry; Procedure: Blood tests; Device: BODPOD; Procedure: MRI (Magnetic Resonance Imaging); Other: Food Diary; Device: CGMS (Continuous Glucose Monitoring System); Other: Questionnaire and Hypo Score; Procedure: Mixed Meal Tolerance Test (MMTT); Procedure: Indirect Calorimetry; Drug: Doubly Labelled Water; Drug: Hepatic Mitochondrial Oxidation breath test

Insulin Pump Therapy Patients

ACTIVE COMPARATOR

Patients with Type 1 Diabetes waiting to start on an Insulin Pump.

Device: Accelerometer; Other: Anthropomentry; Procedure: Blood tests; Device: BODPOD; Procedure: MRI (Magnetic Resonance Imaging); Other: Food Diary; Device: CGMS (Continuous Glucose Monitoring System); Other: Questionnaire and Hypo Score; Procedure: Mixed Meal Tolerance Test (MMTT); Procedure: Indirect Calorimetry; Drug: Doubly Labelled Water; Drug: Hepatic Mitochondrial Oxidation breath test

Healthy Volunteers

OTHER

Participants with no Diabetes.

Device: Accelerometer; Other: Anthropomentry; Procedure: Blood tests; Device: BODPOD; Other: Food Diary; Device: CGMS (Continuous Glucose Monitoring System); Procedure: Mixed Meal Tolerance Test (MMTT); Procedure: Indirect Calorimetry

Interventions

Accelerometer DEVICE

Attach a monitor to participants thigh to measure their physical activity for 7 days. The monitor is called the Activpal Micro.

Also known as: Activpal Micro

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

Anthropomentry OTHER

Take skinfold measurements of participants using Harpenden skinfold calipers.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

Blood tests PROCEDURE

Taking standard clinical blood tests to measure HbA1c, Glucose, FBC, U\&E's, LFT's, Coagulation Screen, Lipid Profile, Thyroid Function, and Tacrolimus for transplant patients.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

BODPOD DEVICE

Measure body composition using a BODPOD machine. This uses Air displacement plethysmography.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

MRI (Magnetic Resonance Imaging) PROCEDURE

MRI Scans of abdomen, particularly the livers of islet transplant and insulin pump patients.

Insulin Pump Therapy Patients; Islet Transplant Patients

Food Diary OTHER

Participants will keep a 7 day weighed food diary.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

CGMS (Continuous Glucose Monitoring System) DEVICE

Participants will wear a CGMS for 7 days to measure their glucose control and pattern over a 7 day period.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

Questionnaire and Hypo Score OTHER

Participants with Type 1 Diabetes will fill in 3 short questionnaires about their Diabetes.

Also known as: Clark and Gold Score and Fear of Hypo Survey

Insulin Pump Therapy Patients; Islet Transplant Patients

Mixed Meal Tolerance Test (MMTT) PROCEDURE

The patients will under go a test which involves taking 30 minute glucose and C-peptide levels (blood test from a cannula) for 3 hours. They will consume 150ml of a mixed meal supplement drink "Fortisip Compact" at the start of the 3 hours, after having no morning insulin, breakfast and not eating anything from midnight the night before.

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

Indirect Calorimetry PROCEDURE

During the Meal Tolerance Test, the patients will be resting on a bed in the research facility and breathing normally into a clear plastic hood. The machine connected to the hood (GEM) will analyse their resting energy expenditure from the gases expired in their breath. They will have the hood on for 2 hours.

Also known as: GEM

Healthy Volunteers; Insulin Pump Therapy Patients; Islet Transplant Patients

Doubly Labelled Water DRUG

The Doubly Labelled water will be prescribed for the participants and they will drink their 100ml dose of the stable isotope. Dose depends on the eight of the participant. The participant will then collect urine samples at home on day 5, 10 and 14 after drinking the water. They will store them in the freezer until they can bring them back to us.

Insulin Pump Therapy Patients; Islet Transplant Patients

Hepatic Mitochondrial Oxidation breath test DRUG

Participants will be given a calculated amount of the stable isotope C-Octanoate, which will be delivered in a water solution. They will then be asked to breath down a small tube into a clear plastic collection bag 10 times over 2 hours.

Also known as: IRIS machine.

Insulin Pump Therapy Patients; Islet Transplant Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Islet transplant and pump therapy
• Male or Female
• Age 18 or over
• Type 1 diabetes.
• On waiting list for islet transplantation or insulin pump therapy.
• Normal renal function (GFR \>60).
• Normal thyroid function (those on thyroxine may be included provided their thyroid function tests are normal).
• Able to understand and undertake the study procedures.
• Able to give signed informed consent.
• Healthy controls
• Male or Female.
• Age 18 or over.
• Glucose tolerant.
• Normal renal function (GFR \>60).
• Normal thyroid function (those on thyroxine may be included provided their thyroid function tests are normal).

You may not qualify if:

• Islet transplant and pump therapy
• Age less than 18
• Impaired renal function (GFR \<60)
• Impaired thyroid function despite therapy
• Unable to adhere to the study timetable.
• Unwilling to give informed consent.
• Healthy Controls
• Age less than 18
• Impaired glucose-tolerance
• Impaired thyroid function
• Impaired renal function (GFR \<60)
• Unable to adhere to the study timetable.
• Unwilling to give informed consent.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hematologic Tests; Magnetic Resonance Spectroscopy; Diet Records; Continuous Glucose Monitoring; Surveys and Questionnaires; Calorimetry, Indirect

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Records; Organization and Administration; Health Services Administration; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Calorimetry

Study Officials

• Shareen Forbes, MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: February 24, 2017
• Study Start: June 1, 2016
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)